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## Protocol Section ### Identification Module **NCT ID:** NCT06433232 **Brief Title:** Effect of Endodontic Treatment on Inflammatory Markers, Disease Activity and Periapical Healing in Rheumatoid Arthritis Patients With Apical Periodontitis : A Prospective Interventional Study **Official Title:** Effect of Endodontic Treatment on Inflammatory Markers, Disease Activity and Periapical Healing in Rheumatoid Arthritis Patients With Apical Periodontitis : A Prospective Interventional Study #### Organization Study ID Info **ID:** Bhavika Bansal #### Organization **Class:** OTHER **Full Name:** Postgraduate Institute of Dental Sciences Rohtak ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Postgraduate Institute of Dental Sciences Rohtak #### Responsible Party **Investigator Affiliation:** Postgraduate Institute of Dental Sciences Rohtak **Investigator Full Name:** Sanjay Tewari **Investigator Title:** principal pgids **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** SUMMARY TITLE: "Effect of endodontic treatment on inflammatory markers, disease activity and periapical healing in rheumatoid arthritis patients with apical periodontitis" RATIONALE: Chronic inflammation plays a pivotal role in rheumatoid arthritis as subjects present with elevated serum levels of numerous cytokines such as IL-1, IL-6, 1L-12, IL-17, tumour necrosis factor-alpha, RANK and RANK Ligand. Periodontal and pulpal inflammation are two major low grade chronic inflammatory diseases of the oral cavity. Apical periodontitis extends from the chronic inflammatory process that originated in the dental pulp to surround the apex of the tooth. Thus Rheumatoid arthritis and apical periodontitis converge upon common pathway of inflammation. The scientific literature has also shown to provide potential link between endodontic infection and rheumatoid arthritis. The evidence of increased prevalence of apical periodontitis in subjects of rheumatoid arthritis is provided mainly by cross-sectional and case control studies. Interventional studies have been performed in subjects with rheumatoid arthritis and periodontal disease, with results depicting beneficial effect of periodontal therapy in patients of rheumatoid arthritis. To best of our knowledge no interventional study has been performed to assess the healing pattern of apical periodontitis in subjects of rheumatoid arthritis and subsequently effect of endodontic intervention on inflammatory profile and disease burden in the same. ### Conditions Module **Conditions:** - Rheumatoid Arthritis AND Apical Periodontitis ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 76 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Rhuematoid arhtritis patients: Change in PAI, hsCRP, ESR, SDAI and quality of life using OHIP-14 will be assessed post root canal treatment **Intervention Names:** - Procedure: ROOT CANAL TREATMENT **Label:** Rhuematoid arhtritis patients **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Systemically healthy patients: Change in PAI, hsCRP, ESR, and quality of life using OHIP-14 will be assessed post root canal treatment **Intervention Names:** - Procedure: ROOT CANAL TREATMENT **Label:** Systemically healthy patients **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Rhuematoid arhtritis patients - Systemically healthy patients **Description:** ROOT CANAL TREATMENT **Name:** ROOT CANAL TREATMENT **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Change in levels of hsCRP **Time Frame:** 12 MONTHS #### Secondary Outcomes **Measure:** Change in levels of ESR **Time Frame:** 12 MONTHS **Measure:** Change in SDAI **Time Frame:** 12 MONTHS **Measure:** Quality of life using OHIP-14 **Time Frame:** 12 MONTHS ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Age of patients 30-65 years 2.Definite diagnosis of Rheumatoid arthritis based on ACR/EULAR 2010 criteria\[28\] i.e a score of 6 or greater out of 10 from the individual scores in four domains: number and site of involved joints (range 0-5), serological abnormality (range 0-3), elevated acute-phase response (range 0-1) and symptom duration (two levels; range 0-1) 3. The periapical index (PAI) will be used to evaluate the periapical status patients with PAI \>or=3 as given by Orstavik\[29\] will be included 4. Presence of total teeth \>/= 12 Exclusion Criteria: 1. Patients with periodontitis, pocket depth and CAL\>5mm (stage 3, 4) will be excluded. 2. Pregnancy; lactation \& contraceptives 3. Patients with any other systemic disease other than Rheumatoid arthritis i.e Diabetes, HIV, Chronic Liver Disease, Chronic Kidney disease and Cardiovascular disease 5. Conditions known to alter systemic inflammatory markers i.e orthopaedic trauma, surgery and viral infections 6. Patients with BMI \>/= 30 7. Medications (during last 3 months) known to affect systemic inflammatory markers (systemic steroids, immunosuppressants, hormone replacement therapy, contraceptives and systemic antibiotics) 8. Smoking - **Gender Based:** True **Gender Description:** ender matched healthy control participants to the same gender rheumatoid arthritis individuals will be analyzed. **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** BHAVIKA BANSAL **Phone:** 8288984027 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** MAYANK ARORA **Phone:** 8295964200 **Role:** CONTACT #### Locations **Location 1:** **City:** Rohtak **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** mayank arora - **Phone:** 8295964200 - **Role:** CONTACT **Country:** India **Facility:** Rheumatology clinic PGIMS ROHTAK **Status:** RECRUITING **Zip:** 124001 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000010483 - Term: Periapical Diseases - ID: D000007571 - Term: Jaw Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M13395 - Name: Periapical Periodontitis - Relevance: HIGH - As Found: Apical Periodontitis - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: HIGH - As Found: Rheumatoid Arthritis - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M13393 - Name: Periapical Diseases - Relevance: LOW - As Found: Unknown - ID: M10601 - Name: Jaw Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000001172 - Term: Arthritis, Rheumatoid - ID: D000010518 - Term: Periodontitis - ID: D000010485 - Term: Periapical Periodontitis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433219 **Brief Title:** Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302) **Official Title:** An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deficiency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302) #### Organization Study ID Info **ID:** MS201924_0002 #### Organization **Class:** INDUSTRY **Full Name:** EMD Serono #### Secondary ID Infos **Domain:** EU trial number **ID:** 2024-511202-23-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-01-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-01-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-26 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Merck KGaA, Darmstadt, Germany #### Lead Sponsor **Class:** INDUSTRY **Name:** EMD Serono Research & Development Institute, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objective of the study is to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse. ### Conditions Module **Conditions:** - Ovarian Cancer **Keywords:** - Ataxia telangiectasia mutated Rad3-related - Ataxia telangiectasia mutated - Poly-ADP ribose polymerase inhibitor resistance - Homologous recombination deficiency ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Tuvusertib (M1774) - Drug: Niraparib **Label:** Tuvusertib with Niraparib **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Tuvusertib (M1774) - Drug: Lartesertib (M4076) **Label:** Tuvusertib with Lartesertib **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tuvusertib with Lartesertib - Tuvusertib with Niraparib **Description:** Tuvusertib will be administered orally **Name:** Tuvusertib (M1774) **Other Names:** - M1774, VXc-400, VRT-1363004, substance code MSC2584415A **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Tuvusertib with Niraparib **Description:** Niraparib will be administered orally **Name:** Niraparib **Other Names:** - GSK3985771, MK-4827 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Tuvusertib with Lartesertib **Description:** Lartesertib will be administered orally **Name:** Lartesertib (M4076) **Other Names:** - M4076, substance code MSC2585823A **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator **Time Frame:** Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years. **Measure:** Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs **Time Frame:** Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years. #### Secondary Outcomes **Measure:** Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator **Time Frame:** Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years. **Measure:** Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator **Time Frame:** Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent. * Participants whose tumor carries germline or somatic deleterious or suspected deleterious mutations in the genes BRCA1 (BReast CAncer gene 1) and BRCA2 (BReast CAncer gene 2), and/or tumors with positive HRD status. The presence of any of these mutations and/or the homologous recombination deficiency (HRD) status will be determined according to routinely used local standard of care tests. Results must be available before screening. * Radiologically confirmed/documented disease progression while on Poly (ADP-ribose) polymerase (PARP) inhibitors therapy in either first or second-line maintenance setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab). Note: Documentation of disease progression must be within 28 days of last PARPi dose taken. Surgical salvage intervention and/or focal ablative therapies are allowed, (further disease progression after these interventions must be documented), AND Clinically benefited from PARPi maintenance prior to documented progression, as defined by at least 6 months of treatment duration with no progressive disease observed, AND either, Progression on first-line maintenance PARPi: Participants are allowed maximum 1 additional line of platinum-based chemotherapy before study entry. (note: treatment-free interval on platinum rechallenge must be \>6 months, with documented disease progression prior to study entry). OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (i.e. PARPi is the last treatment before study entry) * Measurable disease per RECIST v1.1, as assessed by Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months. * Other Protocol defined inclusion criteria. Exclusion Criteria: * Primary platinum-refractory disease defined as disease progression during primary platinum-based chemotherapy or platinum-resistant disease defined as disease progression within 6 months of the last platinum administration in the second-line setting. * History of additional malignancy within 3 years before the date of enrollment. * Known brain metastases, unless clinically stable, i.e. without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention, no evidence of new brain metastases, and on a stable or decreasing dose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for at least 14 days prior to study intervention administration. * Active and/or uncontrolled infection. * History of known hypersensitivity to the active substances or to any excipients (e.g. polysorbate 80) of the study interventions. * Organ transplantation, including allogenic stem cell transplant. * Other Protocol defined exclusion criteria. **Gender Based:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** US Medical Information **Phone:** 888-275-7376 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Communication Center **Phone:** +49 6151 72 5200 **Role:** CONTACT #### Locations **Location 1:** **City:** Rockland **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Please Contact U.S. Medical Information - **Phone:** 888-275-7376 - **Role:** CONTACT **Country:** United States **Facility:** Please Contact U.S. Medical Information **State:** Massachusetts **Zip:** 02370 **Location 2:** **City:** Darmstadt **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Please Contact the Communication Center - **Phone:** +49 6151 72 5200 - **Role:** CONTACT **Country:** Germany **Facility:** Please Contact the Communication Center **Zip:** 64293 #### Overall Officials **Official 1:** **Affiliation:** EMD Serono Research & Development Institute, Inc. **Name:** Medical Responsible **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal. **Description:** We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21 **Info Types:** - STUDY_PROTOCOL - SAP - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union **URL:** http://bit.ly/IPD21 ### References Module #### See Also Links **Label:** Trial Awareness and Transparency website **URL:** https://clinicaltrials.emdgroup.com/en ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000010049 - Term: Ovarian Diseases - ID: D000000291 - Term: Adnexal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000091662 - Term: Genital Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006058 - Term: Gonadal Disorders - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12974 - Name: Ovarian Neoplasms - Relevance: HIGH - As Found: Ovarian Cancer - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: HIGH - As Found: Ovarian Cancer - ID: M4565 - Name: Ataxia - Relevance: LOW - As Found: Unknown - ID: M5773 - Name: Cerebellar Ataxia - Relevance: LOW - As Found: Unknown - ID: M16456 - Name: Telangiectasis - Relevance: LOW - As Found: Unknown - ID: M4566 - Name: Ataxia Telangiectasia - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12972 - Name: Ovarian Diseases - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T519 - Name: Ataxia Telangiectasia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010051 - Term: Ovarian Neoplasms - ID: D000077216 - Term: Carcinoma, Ovarian Epithelial ### Intervention Browse Module - Ancestors - ID: D000067856 - Term: Poly(ADP-ribose) Polymerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M289466 - Name: Niraparib - Relevance: HIGH - As Found: Thigh - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000545685 - Term: Niraparib ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433206 **Brief Title:** Care Needs in Lung Cancer Patients Receiving Immunotherapy **Official Title:** Quality of Life, Symptom Severity, and Care Needs in Lung Cancer Patients Receiving Immunotherapy #### Organization Study ID Info **ID:** 201911078RIND #### Organization **Class:** OTHER **Full Name:** National Taiwan University Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2021-04-21 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Taiwan University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Lung cancer ranks as the leading cause of cancer-related deaths globally and is among the most common malignancies. In recent years, the advancements in immune checkpoint inhibitors have marked a significant breakthrough in the immunotherapy of lung cancer. However, immunotherapy is a relatively new treatment modality, and ongoing clinical trials continue to explore its efficacy. Due to a lack of knowledge about immunotherapy-related care, patients often experience uncertainty and anxiety regarding its effectiveness, resulting in associated care needs. A total of 160 lung cancer patients were included in the study. The research findings revealed statistically significant correlations (p \< 0.05) between the severity of disease, symptomatology, overall health status, functional capacity, cognitive function, disease progression, mood, and general supportive care needs, as well as specific needs of lung cancer patients. Regarding factors influencing care needs, it was found that general supportive care needs were significantly influenced by marital status, average personal monthly income, and disease progression. Additionally, age, surgical history, functional capacity, and cognitive function significantly influenced specific care needs. Based on these statistical findings, it is crucial for nursing staff to closely monitor changes in patients' symptoms and mood and provide timely care and support. Furthermore, future interventions should focus on addressing the heightened needs of lung cancer patients, thereby reducing their dissatisfaction along the cancer treatment journey. **Detailed Description:** Background and Purpose: Lung cancer is a major health concern affecting the Taiwanese population. Immunotherapy represents a novel treatment approach which activates the immune system to combat tumor cells through a series of interactions. However, the side effects associated with immunotherapy can be significant, potentially causing uncertainty and anxiety in patients. Medical decision-making also involves numerous considerations, impacting their psychosocial well-being and subsequent health behaviors. Research in this area remains limited. Therefore, this study aims to (1) explore the quality of life, severity of symptoms, and care needs of lung cancer patients following immunotherapy; (2) investigate the correlations between quality of life, severity of symptoms, and care needs; and (3) identify predictive factors for the care needs of immunotherapy patients. Research Method: This study adopts a cross-sectional research design, conducted at a medical center and a specialized cancer hospital in Taipei City. Recruitment takes place in hospital wards, treatment rooms, and outpatient clinics, utilizing consecutive sampling. Lung cancer patients who have undergone or are currently undergoing immunotherapy are selected. Structured questionnaires are employed, covering demographics, disease treatment characteristics, severity of symptoms, quality of life, functional disability, supportive care needs, fear of disease progression, and qualitative interviews. Quantitative data are analyzed using descriptive and inferential statistics in SPSS version 22.0. The study aims to enroll 180 participants. Expected Results: The anticipated findings of this study are expected to provide valuable insights for clinical healthcare professionals. They can aid in understanding patients' needs, contribute to the development of post-immunotherapy care guidelines for lung cancer patients, and serve as essential references for healthcare reimbursement policies. These outcomes may help alleviate patient burden and enhance quality of life. It is expected that demographic characteristics, disease treatment characteristics, quality of life, severity of symptoms, and the extent of care needs will be positively correlated and serve as important predictors of care needs. ### Conditions Module **Conditions:** - Lung Cancer, Immunotherapy, Quality of Life, Symptom Severity, Care Needs ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 180 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** no intervention **Name:** no intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Care Needs in Lung Cancer Patients Receiving Immunotherapy **Time Frame:** 1year #### Secondary Outcomes **Measure:** Quality of Life in Lung Cancer Patients Receiving Immunotherapy **Time Frame:** 1year **Measure:** Symptom Severity in Lung Cancer Patients Receiving Immunotherapy **Time Frame:** 1year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Individuals diagnosed with malignant lung tumors based on imaging or post-surgical histopathological examination results by specialized physicians. 2. Individuals who have received immunotherapy in the past or are currently undergoing immunotherapy. 3. Research participants who are conscious, aged 20 years or older, able to communicate in Mandarin or Taiwanese, capable of completing the questionnaire, willing to participate in the study, and have signed the research consent form. Exclusion Criteria: 1. Individuals with significant cognitive impairments who are unable to complete the questionnaire. 2. Individuals who are unable to communicate in Mandarin or Taiwanese. **Minimum Age:** 20 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Using consecutive sampling, lung cancer patients who have received or are currently undergoing immunotherapy will be selected from a medical center and a specialized cancer hospital in northern Taiwan. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Meng Ping Hsiao, master **Phone:** +886 919865349 **Role:** CONTACT #### Locations **Location 1:** **City:** Taipei **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Meng Ping Hsiao, Master - **Phone:** +886 919865349 - **Role:** CONTACT **Country:** Taiwan **Facility:** National Taiwan University Cancer Center **Status:** RECRUITING **Zip:** 106 #### Overall Officials **Official 1:** **Affiliation:** NTUCC **Name:** Meng Ping Hsiao, master **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433193 **Brief Title:** Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients **Official Title:** Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients #### Organization Study ID Info **ID:** DIALYSS-CLI-CIP02 #### Organization **Class:** INDUSTRY **Full Name:** Nextkidney S.A. ### Status Module #### Completion Date **Date:** 2024-04-24 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-24 **Type:** ACTUAL #### Start Date **Date:** 2024-02-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Nextkidney S.A. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary aim of this early feasibility clinical trial is to assess the biochemical safety of dialysate regeneration with the optimised PAK HDsorbent cartridge in a limited number (n=3) of participants and treatments (one therapy per subject). As a secondary aim, we will assessthe therapy efficacy of the PAK HD sorbent therapy in short-daily hemodialysis (SDHD) and compare it to that of conventional CHD underthe same therapy settings. Following up from the preceding FIH trial, this continuation aims at demonstrating that the optimised PAK HD sorbent system has overcome previous problems of increased dialysate acidity and provides improved control over the patient's acid-base balance. ### Conditions Module **Conditions:** - End Stage Renal Disease - ESRD ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DEVICE_FEASIBILITY #### Enrollment Info **Count:** 3 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study will be performed as a prospective, non-randomised, single arm two-period cross-over study comparing conventional CHD to PAK HD. All adverse events will be recorded and reviewed. Only one subject will enter each study period at a time. **Intervention Names:** - Device: PAK HD Sorbent Therapy **Label:** PAK HD Sorbent Study **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - PAK HD Sorbent Study **Description:** Study Period 1: Subjects will receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, one 4h CHD therapy will be performed at a dialysate flow rate (QD) of 300mL/min, identical to the dialysate flow rate of the PAK HD sorbent therapy. Blood and dialysate samples will be collected during treatment and sent for analysis, for comparison with PAK HD sorbent treatment. Study Period 2: Subjects will again receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, a 2h PAK HD +/- 2h CHD therapy will be performed. Blood and dialysate samples will again be collected during treatment and sent for analysis, for comparison with the CHD therapy of the first period. After completion of study period 2 (PAK HD +/- CHD), subjects will be observed for a minimum duration of 1 h in the hospital after which they may go home if the post-dialysis period was uneventful. **Name:** PAK HD Sorbent Therapy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The clinical safety of the PAK HD will be evaluated in terms of the following primary endpoints: a) Absence of serious adverse events (SAE) b) Absence of critical change in patient's clinical condition and vital parameters (Blood pressure, heart rate, body temperature and respiratory rate and pulse oximetry) during treatment. c) Absence of critical change in haematology and biochemistry immediately before the start of therapy and immediately after completion of therapy, including acid-base state, electrolytes, and ammonia. **Measure:** The primary objective of this early feasibility clinical trial is to assess the (short term) clinical safety of the PAK HD sorbent treatment in a limited number of patients and treatments. **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** The therapy efficacy will be evaluated with the secondary endpoint: a) PAK HD therapy provides equivalent toxin clearances for urea, phosphate and creatinine as compared to CHD **Measure:** The secondary objective of this study is to evaluate the efficacy of the PAK HD therapy in comparison to CHD, in terms of uremic toxin removal efficacy (urea, creatinine and phosphate). **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subjects must be adults \>/= 21 years old and \<80 years old. 2. Subjects must be weighing \>/= 55kg and \<90kg (patient's dry weight). 3. Subjects must have stable haemoglobin \>/= 10.5g/dL 2 months prior to enrolment 4. Subjects' pre-dialysis serum values must be within the following range, 2 months prior to enrolment: Patient allowable serum biochemistry ranges Allowable pre-dialysis serum values Na \>/= 132 mmol/L or \</= 145mmol/L HCO3 \>/= 15mmol/L or \</= 30mmol/L K \>/= 3.5mmol/L or \</= 5.8mmol/L 5. Subjects on stable on thrice weekly 4-h HD schedule. Stability is defined as: * Haemodynamic stability during dialysis (absence of hypotensive events and symptomatic arrhythmias), no angina pectoris, AND * No altered level of consciousness during dialysis. 6. Subjects with a well-functioning vascular access (native fistula graft): * capable of providing a blood flow rate of \>/= 250 mL/min, AND * no vascular access revision and stable shunt flow for at least 4 weeks prior to enrolment. 7. Subjects capable of understanding the informed consent form and give informed consent. 8. Subjects willing and able to comply with study procedures and to attend all study follow-up visits. 9. Subjects who are female of reproducible age to practice birth control methods. 10. Subjects can be either gender. Exclusion Criteria: 1. Subjects with haemoglobin level of \<10.5g/dL in any measurement 2 months prior to enrolment. 2. Subjects with the following pre-dialysis serum values in any measurement 2 months prior to enrolment: * sodium concentration \<132 mmol/L or \> 145mmol/L * bicarbonate \<15mmol/L or \>30mmol/L * plasma potassium concentration \<3.5mmol/L or \>5.8mmol/L * urea \<15mmol/L or \>28 mmol/L 3. Subjects with severe hypertension: systolic blood pressure \> /=180 mmHg, diastolic blood pressure \>/=120 mmHg in any officemeasurement less than 4 weeks prior to enrolment. 4. Subjects with chronic obstructive pulmonary disease or any respiratory disease that may predispose to CO2 retention. 5. Subjects with impaired liver function. Impaired liver function is defined as an elevated ALT (alanine aminotransferase) by 3-fold orgreater above the upper limit of normal. 6. Subjects with episodes of haemolysis in any measurement 3 months prior to enrolment. 7. Subjects with a central venous catheter. 8. Subjects with vascular access dysfunction (whether or not requiring an intervention), i.e. failure to achieve and/ or sustain a bloodflow of \>/=250 mL/min and/or signs of compromised vascular access patency (according to the opinion of the investigator) within 4weeks prior to enrolment. 9. Subjects with vascular access related infection less than 4 weeks prior to enrolment 10. Subjects requiring an average ultrafiltration volume \>2.8 L per 4-h treatment in mid-week dialysis session in the past 4 weeks priorto enrolment. 11. Subjects who are on heparin free dialysis 12. Subjects who are unable to provide informed consent. 13. Subjects who are unable to comply with study procedures. 14. Subjects with psychosocial problems which may negatively influence dialysis treatment. 15. Subjects who participated in another clinical intervention or device trial less than 12 weeks prior to enrolment, are currentlyparticipating or intend to participate in such a trial. 16. Subjects who are pregnant, breast feeding, or planning a pregnancy within the study period. 17. Subjects with a life expectancy \<1 year. 18. Subjects who are anticipating a living donor kidney transplantation within \< 2 months of the study period. 19. Subjects with recent history of drug and/or alcohol abuse in the last 3 months prior to enrolment. **Maximum Age:** 79 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Singapore **Country:** Singapore **Facility:** National University Hospital Investigational Medicine Unit **Zip:** 119074 #### Overall Officials **Official 1:** **Affiliation:** National University Hospital, Singapore **Name:** Titus Wai Leong Lau, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: End Stage Renal Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007676 - Term: Kidney Failure, Chronic ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M18008 - Name: Dialysis Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433180 **Acronym:** ICEBOAT **Brief Title:** Study of Fecal Microbiota Transplantation (FMT) in Severe IBS Patients **Official Title:** A Prospective, Multi-center, Double Blind Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule Versus Placebo in Severe Irritable Bowel Syndrome (IBS). #### Organization Study ID Info **ID:** APHP180583 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris #### Secondary ID Infos **ID:** 2019-003433-41 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2029-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective of this protocol is to evaluate the efficacy of fecal microbiota transplantation (FMT) using oral capsules containing frozen stools vs sham FMT on IBS severity score at 12 weeks in patients with severe irritable bowel syndrome refractory to conventional treatments. **Detailed Description:** Irritable bowel syndrome (IBS) is a chronic disease. It affects about 4.4 to 10 % of the French general population (according to Rome III or Rome IV definition) and is the most frequent functional bowel disorder in patients visiting general practitioners or gastroenterologists. The efficacy of treatments is often limited, in particular form the case severe of IBS (IBS-SSS\>300) which concerns at least 20 to 25% of patients and IBS can cause significant deterioration in quality of life. In this context, microbiota could become a potential therapeutic target, and replacement of the abnormal fecal microbiota by an "healthy" one, especially in patients refractory to previous treatment and with severe symptoms, is a seducing new therapeutic strategy. The primary outcome is an improvement in the IBS-SSS score level at 12 weeks after taking a oral capsules of FMT in patients with severe IBS. ### Conditions Module **Conditions:** - Irritable Bowel Syndrome **Keywords:** - fecal microbiota transplantation - irritable bowel syndrome - frozen capsule - Rome IV - IBS-SSS ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Oral, capsulized, frozen capsules without fecal matter but containing cryopreservation solution will be administered at the same volume and same time point as in the experimental group. Taken in one day in two separate meals. Administration of the sham after colon cleaning. **Intervention Names:** - Drug: Administration of the sham (PLACEBO) **Label:** Administration of the sham (PLACEBO) **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Oral, capsulized, frozen fecal microbiota transplantation FMT delivering approximatively 24 g of stools taken in one day in two separate meals. Administration of the FMT after colon cleaning. **Intervention Names:** - Drug: Administration of fecal microbiota transplantation ( FMT capsules) **Label:** Administration of fecal microbiota transplantation ( FMT capsules) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Administration of fecal microbiota transplantation ( FMT capsules) **Description:** Oral, capsulized, frozen fecal microbiota transplantation FMT delivering approximatively 24 g of stools taken in one day in two separate meals. Administration of the FMT after colon cleaning. **Name:** Administration of fecal microbiota transplantation ( FMT capsules) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Administration of the sham (PLACEBO) **Description:** Oral, capsulized, frozen capsules without fecal matter but containing cryopreservation solution will be administered at the same volume and same time point as in the experimental group. Taken in one day in two separate meals. Administration of the sham after colon cleaning. **Name:** Administration of the sham (PLACEBO) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks in patients with irritable bowel syndrome with severe disease refractory to conventional treatments. Decrease in IBS severity at 12 weeks is defined by the percentage of patients having at least a 75 points decrease in IBS-SSS. **Measure:** Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 75 points decrease in IBS-SSS. **Time Frame:** At 12 weeks #### Secondary Outcomes **Description:** To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks in patients with irritable bowel syndrome with severe disease refractory to conventional treatments (at least a 50 points decrease in IBS-SSS) **Measure:** Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 50 points decrease in IBS-SSS. **Time Frame:** At 12 weeks **Description:** patient's microbiota 12 weeks after FMT closer to that of the donor than the patient's microbiota before FMT. The composition of the patient's fecal microbiota 12 weeks after FMT will be compared to the patient's microbiota before transplantation and to the donor using the Sorensen similarity index. The FMT will be considered as a success if the Sorensen index \[patient after FMT vs donor\] \> Sorensen index \[patient after FMT vs patient before FMT\] and if the Sorensen index \[patient after FMT vs donor\] ≥ 0,6. The composition of fecal microbiota will be measured by pyrosequencing (16S RNA). **Measure:** FMT success **Time Frame:** At 12 weeks **Description:** Intestinal microbiota composition and diversity at week 12 and 24 assessed by 16s sequencing. Microbiota composition and diversity assessed by 16s sequencing at week 12 and 24, compared to baseline and to healthy volunteers donor's microbiota. Microbiota composition will be assessed using Qiime pipeline and analyzed at all phylogenetic levels. Diversity will be evaluated using Shannon index, Simpson index, Chao1 index and number of observed species. **Measure:** Intestinal microbiota composition at week 12 and 24 by 16s sequencing. **Time Frame:** at week 12 and 24 **Description:** Efficacy (decrease in IBS severity \>75 points) according to FMT success. **Measure:** Efficacy (decrease in IBS severity >75 points) at week 24 according to FMT success. **Time Frame:** At 24 weeks **Description:** Efficacy according to EMA (European Medical Agency) endpoint in IBS on composite criteria at 12 or 24 weeks **Measure:** EMA Endpoint at week 12 and 24 defined as a patient who fulfils the response criteria (simultaneous improvement of transit and abdominal pain) displayed in the following for at least 50% of the observation time. **Time Frame:** at week 12 and 24 **Description:** IBS severity at 12 weeks by donors (one donor giving FMT to several patients) **Measure:** Percentage of responders in the different subgroups IBS-D, IBS-C and IBS-M using the primary endpoint at week 12 and 24. **Time Frame:** at week 12 and 24 **Description:** IBS severity at 12 weeks and at 24 weeks by IBS subtypes according to transit pattern. The score ranges from 0 to 500 ( Remission : 0 to 74, Mild : 75 to 175, Moderate : 175 to 300 and Severe : \>300). **Measure:** Mean IBS-SSS (IBS severity), comparison between FMT and placebo at 12 and 24 weeks) **Time Frame:** at week 12 and 24 **Description:** IBS Quality of life at 12 weeks and 24 weeks. Irritable Bowel Syndrom- Quality of Life (IBS-QoL) at 12 weeks and 24 weeks, IBS-QoL ranges from 0 ( worse) to 100 (better). **Measure:** Mean IBS-QoL score (IBS Quality of life) comparison between FMT and placebo at 12 and 24 weeks (Drossman et al. 2000) **Time Frame:** at week 12 and 24 **Description:** Patient's perception of FMT (questionnaire for correct assessment of FMT or placebo and FMT acceptability) (Annex D), secondary effects of FMT **Measure:** Patient's perception of FMT : - Questionnaire for correct assessment of FMT or placebo and FMT acceptability) at V2 (FMT administration). - Questionnaire for assessment of FMT secondary effects at V3. **Time Frame:** V2: five weeks after inclusion. V3:Four weeks after V2 **Description:** Safety (Serious Adverse Events, Adverse Events) compared between groups. **Measure:** Safety (Serious Adverse Events, Adverse Events) compared between groups. **Time Frame:** through study completion, at 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years and \< 75 years * IBS defined according to Rome IV definition (IBS-C, IBS-D or IBS-M) * Severe disease (IBS-SSS \>300) and refractory to at least two previous treatment strategies:among the following : anti-spasmodic and/or laxatives (polyethylene glycol) or anti-diarrheal drug (loperamide) according to transit subtype for one month, antidepressants for 2 months, probiotics (ALFLOREX, SMEBIOCTA, PROBIOLOG FLORVIS) for 1 month, hypnosis for 5 hypnosis sessions in two months, Cognitive Behavioral Therapies for 2 months, colestyramine for IBS-D patients for 1 month, ondansetron for IBS-D patients and for 1 month, ebastine for 2 months, L-glutamine (5g x3/day, for 2 months, Gelsectan for one month, Biofeedback for 15 sessions in IBS-C (3 months), Low FODMAP diet for 1 month, gluten free diet for 1 month, standard dietary advice from the NICE (UK) for 1 month, increase in physical activity. * Patient with health insurance (AME excepted) * Informed written consent * For women with childbearing potential, efficient contraception for the duration of the participation to the study Exclusion Criteria: * Other chronic gastrointestinal disease (celiac disease, inflammatory bowel disease) * participants if there is a reason to suspect an alternative diagnosis to the IBS complaints * Surgical intervention in the gastrointestinal region except for appendectomy, hernia repair, cholecystectomy and hemorroidectomy * Treatment preceding FMT with: antibiotics, antifungic or probiotics treatment \< 4 weeks, or factors that may affect the composition of intestinal microbiota * Abuse of alcohol or drugs * Pregnancy or breastfeeding * Participation in any other interventional study * Patients under legal protection. * Acute COVID-19 infection * Presence of systemic disease, immune deficiency or treatment with immune-modulators * Severe psychiatric disorder * Participants who were assessed as likely to be noncompliant (ie, not adhering to the tasks they were to perform as participants) **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jean Marc SABATE, Pr **Phone:** 01 48 95 54 34 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nacira DARGHAL, PhD **Phone:** 01 48 95 74 73 **Role:** CONTACT #### Locations **Location 1:** **City:** Bobigny **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jean MARC SABATE, Pr - **Phone:** 01 48 95 54 34 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Nacira DARGHAL, PhD - **Phone:** 01 48 95 74 73 - **Role:** CONTACT **Country:** France **Facility:** Gastro-enterology department, Avicenne Hospital **Zip:** 93000 #### Overall Officials **Official 1:** **Affiliation:** Assistance Publique - Hôpitaux de Paris **Name:** Jean Marc SABATE, Pr **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000003109 - Term: Colonic Diseases, Functional - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M25118 - Name: Irritable Bowel Syndrome - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M6337 - Name: Colonic Diseases, Functional - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000043183 - Term: Irritable Bowel Syndrome - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433167 **Brief Title:** Investigation of Gait Pattern in Idiopathic Scoliosis **Official Title:** Investigation of Gait Pattern in Idiopathic Scoliosis #### Organization Study ID Info **ID:** Iayas9 #### Organization **Class:** OTHER **Full Name:** Gazi University ### Status Module #### Completion Date **Date:** 2025-01-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gazi University #### Responsible Party **Investigator Affiliation:** Gazi University **Investigator Full Name:** İnci Hazal Ayas **Investigator Title:** Research asistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Scoliosis is a condition characterized by an abnormal curvature of the spine, which can affect an individual's gait. Scoliosis can alter body balance and weight distribution. Pedobarographic analysis identifies imbalances and abnormal pressure points by measuring the distribution of pressure applied to the sole of the foot. This examination helps detect abnormalities in the gait mechanics of individuals with scoliosis. Gait analysis can identify long-term foot and leg problems caused by scoliosis at an early stage, allowing for early interventions to prevent more serious issues. The aim of this study is to analyze gait in individuals with idiopathic scoliosis and compare it with that of healthy individuals. The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician. The gait patterns of the patients will be evaluated using pedobarography. Information about the type and degree of scoliosis will be obtained from hospital records. The results of this study may provide an objective and detailed evaluation of gait and pressure distribution disorders in individuals with scoliosis and may contribute to more effective treatment plans. ### Conditions Module **Conditions:** - Idiopathic Scoliosis ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patient group for this research comprises patients diagnosed with idiopathic scoliosis, a condition characterized by abnormal lateral curvature of the spine of unknown cause. **Intervention Names:** - Other: Pedobarographic analysis **Label:** Idiopathic Scoliosis #### Arm Group 2 **Description:** Healthy control group is healthy individuals without any diagnosed disease. **Intervention Names:** - Other: Pedobarographic analysis **Label:** Healthy control ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy control - Idiopathic Scoliosis **Description:** During the pedobarographic analysis, the patient takes steps on the platform at a regular walking speed, with arms relaxed at the sides, following a natural gait. In static analysis, measurements are taken while the patient remains stationary on the platform with arms in a relaxed position beside the body. Five measurements are separately recorded for both feet during the phases of stepping, heel strike, and toe lift. These measurements capture the highest pressures on the back of the foot, the middle part of the foot, and the inner, middle, and lateral sides of the front of the foot, including the toes. The pressure, force, and pressure-time integral corresponding to each area are then used to determine how and for how long these areas are exposed to pressure. **Name:** Pedobarographic analysis **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This assessment uses a specialized device called a pedobarograph, which consists of pressure sensors embedded in a platform. When a person stands or walks on the pedobarograph, the sensors record the pressure exerted by different parts of the foot. The resulting data is then used to create detailed pressure maps and graphs that highlight areas of high and low pressure. **Measure:** Pedobarography **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of idiopathic scoliosis by an orthopedist * The Cobb angle measured on the standard scoliosis radiograph should fall within the range of 10°-45°. Exclusion Criteria: * Presence of any orthopedic or neurological disease affecting trunk and extremity mobility, excluding scoliosis. * History of previous spine or orthopedic surgery. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 12 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician and 30 healty control without scoliosis. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ukanatlı@gazi.edu.tr **Name:** Ulunay Kanatlı, Proff **Phone:** (0312) 216 26 01 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** İnci H Ayas, Msc **Phone:** (0312) 216 26 01 **Role:** CONTACT #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Gazi University Hospital **Zip:** 06500 #### Overall Officials **Official 1:** **Affiliation:** Gazi University **Name:** İnci H Ayas, Msc **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Gazi University **Name:** Furkan Aral, MD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Gazi University **Name:** Burak Oklaz, MD **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** Gazi University **Name:** Ulunay Kanatlı, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013121 - Term: Spinal Curvatures - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15417 - Name: Scoliosis - Relevance: HIGH - As Found: Scoliosis - ID: M15918 - Name: Spinal Curvatures - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012600 - Term: Scoliosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433154 **Brief Title:** Arthroscopy of the Temporomandibular Joint. On Jaw Mobility, Pain and HRQoL **Official Title:** Arthroscopic Lysis and Lavage in Patients With Internal Derangement of the Temporomandibular Joint: A Retrospective Cohort Study on Jaw Mobility, Pain and Health-related Quality of Life #### Organization Study ID Info **ID:** 230_20211018_073 #### Organization **Class:** OTHER **Full Name:** Lund University Hospital ### Status Module #### Completion Date **Date:** 2024-03-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2023-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lund University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the present study is to retrospectively investigate whether arthroscopic treatment in patients with TMD symptoms depending on internal derangement of the temporomandibular joint (TMJ) gives a satisfying result on the patient's quality of life. Based on previous studies it is hypothesized that patients suffering from TMD depending on internal derangement would through Patient Reported Outcome Measures (PROM) evaluate the treatment efficacy from an arthroscopic treatment as a benefit to their quality of life. Further, the study intends to find out if the patient reported outcome measures (PROM) on health-related quality of life (HRQoL) outcome correlates with clinical follow-up measures after arthroscopic treatment of internal derangement of the temporomandibular joint. The primary objective is to measure the correlation between the results from a HRQoL questionnaire and mouth opening. Secondary, the effect of mouth opening on HRQoL is being explored. The primary prediction variable is the surgical treatment. Outcome variables are treatment evaluation quality of life (PROM) based on a validated questionnaire; Jaw Functional Limitation Scale (JFLS), age, gender, time from diagnosis to treatment, severity of symptoms (pain, mouth opening ability) and time from treatment to evaluation. **Detailed Description:** Sample Patients that on referral and examination in 2006 to 2019 at the department of Oral and Maxillofacial Surgery, Skåne University Hospital (SUS) was diagnosed with Temporo Mandibular dysfunction (TMD), will be recruited for participation in the study. Patients aged over 20 years with a dysfunction presenting painful clicking or locking of the Temporomandibular Joint (TMJ), that underwent an arthroscopic treatment the TMJ on one side will be asked for a follow-up. The indication for surgical treatment of these patients was anterior disc displacement combined with pain or "Closed Lock" (disc displacement without reduction). The clinical classification is based on general medical history, history of dysfunction (debut, duration, frequency, character, diurnal variation, symptoms relief, symptoms accentuation), clinical recordings (muscle palpation, joint palpation, recordings of jaw movements and provocation maneuvers, eg Krogh-Poulsen test). The referred patients with TMD were, before selected to arthroscopic treatment, separated into joint associated TMD or muscular associated TMD. Patients with only muscular or mainly muscular symptoms were excluded from arthroscopic treatment and were offered alternative treatment. An important measurement for this selection is the Krogh-Poulsen test. The surgical treatment was carried out by three Oral and Maxillofacial surgeons with equal clinical experience. The sample was during the study period equally distributed between the surgeons. Patients with generalized joint disease, previous surgical treatment in the TMJ, less than 12 months of follow up time and/or had additional surgical treatment during the study period will be excluded from the study. Surgical Method Surgical approach to the TMJ was established through a transcutaneous preauricular stab entry with a sharp 1,9 mm trocar (KARL STORZ SE \& Co. KG, Tuttlingen, Germany) to the upper joint compartment. A second entry was made with a 1 mm syringe for drainage of the saline solution used for lavage of the upper joint compartment through the trocar cannula. Arthroscopic inspection and visual recording of the upper joint compartment was performed with an optical instrument placed through the trocar cannula. The optical instrument was replaced by a blunt tip, which was used for releasement of adherences between the joint surfaces, as well as stretching of the synovia (lysis). The upper joint compartment was flushed with a minimum of 200ml saline solution (lavage). Finally 1 ml morphine 10 mg/ml was injected through the drainage syringe for postoperative pain relief. Postoperatively the patient was instructed in a jaw mobility training programme, NSAID's (Ibuprofen 400mg orally every 6 to 8 hours) and jaw rest (not to chew) for at seven to thirty days. The duration of the postoperative regime was decided at weekly follow-ups. Variables The primary prediction variable is the surgical treatment. The primary outcome variable is a treatment evaluation quality of life questionnaire score, based on a validated questionnaire; Jaw Functional Limitation Scale (JFLS). The questionnaire will be tested for reliability through repeated recording with at least 2 months gap between for 30 of the patients. Other predictor variables that could affect the treatment outcome are age, gender, time from diagnosis to treatment, severity of symptoms (pain, mouth opening ability), time from treatment to evaluation, postoperative jaw mobility and improvement of jaw mobility. After the patients have been consented for the study, they will be asked to fill in the Patient Reported Outcome Measures (PROM) questionnaire on self-perceived jaw function (JFLS). The questionnaire will be sent out to all included patients during 2022. Retrospectively, the following data will be recorded from patient records: gender, age (at surgery), jaw movements, pain, pre surgical diagnosis (clinical) and surgical diagnosis (arthroscopic). Statistical methods The sample size is based on a total number of 500 patients to be recruited for the enquiry study. In addition, 4000 patients will be included for analysis of journal records alone. Analysis will use mean values, confidence intervals, standard deviations, the Cox regression for evaluation of clinical records treatment outcome and logistic regression for the PROM evaluation. Differences in mouth opening and pain scores, preoperatively and postoperatively will be compared with McNemar's test. Wilcoxon's paired-sample test will be used for analyzing mouth opening before and after surgery as a numeric variable. Mann-Whitney-test will be used to detect differences between questionnaire responses and clinical findings, i.e. pain and mouth opening. The limit for significant difference will be set to p=0.05. Two-sided p-values will be used. A correlation analysis (Spearman) for postoperative mouth opening and JFLS-score, and progression of mouth opening and JLFS-score will be used. ### Conditions Module **Conditions:** - Arthroscopic Surgery - Temporomandibular Joint - Health-Related Quality Of Life - Follow-Up Studies - Observational **Keywords:** - Arthroscopy - TMJ - PROM - HRQoL ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 127 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Arthroscopic lysis and lavage in patients with internal derangement of the temporomandibular joint. Retrospective observational follow-up cohort trial. **Intervention Names:** - Procedure: Arthroscopic surgery **Label:** Arthroscopic surgery to the temporomandibular joint ### Interventions #### Intervention 1 **Arm Group Labels:** - Arthroscopic surgery to the temporomandibular joint **Description:** Arthroscopic treatment (lysis and lavage) of internal derangement of the temporomandibular joint. **Name:** Arthroscopic surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Measured range of mandibular movements. **Measure:** Jaw mobility **Time Frame:** At least one year follow-up after surgery. #### Secondary Outcomes **Description:** Patient reported outcome measure with a HRQoL questionaire. **Measure:** Health Related Quality of Life (HRQoL) **Time Frame:** At least one year follow-up after surgery. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients referred to the Department of Oral and Maxillofacial Surgery, Lund University Hospital between 2006 to 2019 with a temporomandibular dysfunction presenting painful clicking or locking of the TMJ and has underwent an arthroscopic treatment the TMJ on one side. Patients aged over 20. Exclusion Criteria: Patients with only muscular or mainly muscular originated TMJ symptoms. Present generalized joint disease, previous surgical treatment in the TMJ, less than 12 months of follow up time and patients which have had additional surgical treatment during the study period. **Minimum Age:** 20 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients which had surgical treatment, were anterior disc displacement combined with pain or "Closed Lock" (disc displacement without reduction). Patients aged over 20. ### Contacts Locations Module #### Locations **Location 1:** **City:** Lund **Country:** Sweden **Facility:** Dept Oral and Maxillofacial Surgery **Zip:** 22185 **Location 2:** **City:** Lund **Country:** Sweden **Facility:** Martin Bengtsson **Zip:** 22350 #### Overall Officials **Official 1:** **Affiliation:** Lund University Hospital **Name:** Martin Bengtsson, DDS, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Bengtsson M, Fransson P. Do patient-reported outcome measures correlate with clinical follow-up after arthroscopic treatment of internal derangement of the temporomandibular joint? J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):e21-e26. doi: 10.1016/j.jormas.2021.03.003. Epub 2021 Apr 9. **PMID:** 33845189 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433141 **Brief Title:** Evaluation of Bioflex Crowns Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars **Official Title:** Evaluation of Clinical Performance, Parent's Satisfaction, Gingival Health and Bacterial Effects of Bioflex Crowns & Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars: A Randomized Clinical Trial #### Organization Study ID Info **ID:** 966/5604 #### Organization **Class:** OTHER **Full Name:** Al-Azhar University ### Status Module #### Completion Date **Date:** 2025-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-03-30 **Type:** ACTUAL #### Start Date **Date:** 2023-12-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Al-Azhar University #### Responsible Party **Investigator Affiliation:** Al-Azhar University **Investigator Full Name:** kareem ragab abdallah el hosary **Investigator Title:** head of dental depertment -tanta militery hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will be conducted to evaluate clinical performance, parent's satisfaction, gingival health and bacterial effects of Bioflex crowns \&Endocrowns compared to ready-made zirconia Crowns on Pulpotomized primary molars **Detailed Description:** Intervention: Pulptomy Procedures The tooth will be anaesthetized. Then, it will be isolated using a rubber dam. Caries will be removed with a sterile non-end cutting bur # 558 to complete the removal of the pulp chamber roof under copious water coolant spray. Coronal pulp tissue remnants will be removed with a sharp, sterile excavator. A piece of cotton soaked with formocresol will be inserted into the pulp chamber for 5 minutes. After removing the formocresol pellet, a thick mix of zinc- oxide/eugenol paste will be packed into the pulp chamber to seal the orifices. Restoration of the tooth: According to the groups restoration will be as the following: Group A: Endocrowns tooth preparation, scanning, cementation: For the endocrowns A layer of light -cured glass ionomer cement ° of 1 mm thickness will be applied over the ZOE- to isolate it from the successive resin based restorations and adhesives- leaving a minimum of 3 mm of the pulp chamber to provide an adequate thickness for the endocrown core. Round-end tapered stone will be used to achieve depth cuts of 1.5 mm for occlusal clearance A wheel stone will complete the occlusal reduction and making butt joint finish line. Tapered stone of 8-degree angle will be used to prepare axial wall flared, the pulp chamber walls to a standard degree of divergence. Abrasive rubber tip will be used to smoothening and rounding the internal angles giving a polished and smoothed preparation. Endocrown will be manufactured using CAD/CAM technology internal wall of crown will be treated with etchant material, rinsed, dried then silane coupling agent Dual-cure resin cement will be applied on the crown fitting surface for endocrown cementation. Group B: Preformed Bioflex crowns According to manufacturer instruction the preparation will be as the follow: Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected. Tooth preparation will be carried out with a tapered diamond bur for occlusal reduction by 1-1.5 mm, including the central groove. The proximal preparation will be around 0.5 mm to clear the contact area Placement of the crown will be achieved by a snug fit followed by contouring using a Hover's plier. Crown cementation will be carried out using glass ionomer cement and removal of excess cement using floss or explorer. Group C: performed zirconia crowns Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation. A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected. A diamond bur will reduce the occlusal surface by 1.5-2 mm Interproximal contacts will be prepared with a tapered fissure bur. About 1-2 mm sub gingival preparation will be performed The selected crown will be placed and checked. The passive fit of the crown will be assessed and will be luted with glass ionomer cement. Consistent firm finger pressure will be applied during cementation. Observations: Clinical Performance Assessment Retention, marginal adaption, fracture of the restoration were scored using a modified United States Public Health Service (USPHS) criterion. Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI. Preparation time and cementation assessment using stop watch to record time from preparation start till final restoration cementation. Clinical performance and oral status will be assessed at follow-up periods of 3 (T1), 6 (T2), and 12 (T3) months. At the end of the follow-up (T3), parent's satisfaction analysis toward the color, shape, and size of three restorations will be adopted to directly evaluate their satisfaction toward their children's restorations. Parents' responses were rated on a 5-point Likert-type scale.Microbiological analysis: The swabs will be collected before preparation of crowns, 3 months, 6 months and 12 months after cementation. The number of Streptococcus Mutans, lactobacillus will be digitally counted. Swabs will be taken from occlusal surface by means of the tips of sterile cotton The number of Streptococcus Mutans, lactobacillus will be digitally counted. Swabs will be taken from occlusal surface by means of the tips of sterile cotton Samples will be preserved in a transporting medium tube containing 9ml thioglycolate broth medium. All specimens were transported immediately to microbiological lab. ### Conditions Module **Conditions:** - Primary Teeth ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 74 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** bio-flex crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year **Intervention Names:** - Procedure: treatment option for primary second molar **Label:** bio-flex crown **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** endo-crown will be used as a final restoration for pulp treated primary molar, after pulpotomy procdure endo-crown preperation design will be done and CAD/CAM, endo crown will be luted according to e-max protocol clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year **Intervention Names:** - Procedure: treatment option for primary second molar **Label:** endo-crown **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** zirconia crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown after preperation of tooth and use try-in kit to select siutable size ,zirconia is sensitive for blood contamination , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year **Intervention Names:** - Procedure: treatment option for primary second molar **Label:** zirconia crown **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - bio-flex crown - endo-crown - zirconia crown **Description:** final restoration for primary second molars **Name:** treatment option for primary second molar **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** number of Streptococcus Mutans, lactobacillus will be digitally counted. **Measure:** Microbiological analysis **Time Frame:** follow up will be 3,6,9,12 month #### Primary Outcomes **Description:** Retention were scored using a modified United States Public Health Service (USPHS) criterion. **Measure:** retention of bio-flex crown,zirconia, and endo-crown **Time Frame:** follow up will be 3,6,9,12 month **Description:** marginal adaptation were scored using a modified United States Public Health Service (USPHS) criterion. **Measure:** marginal adaptation of bio-flex crown,zirconia, and endo-crown **Time Frame:** follow up will be 3,6,9,12 month **Description:** fracture of restoration were scored using a modified United States Public Health Service (USPHS) criterion. **Measure:** fracture of restoration of bio-flex crown,zirconia, and endo-crown **Time Frame:** follow up will be 3,6,9,12 month **Description:** • Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI. **Measure:** gingival health of bio-flex crown,zirconia, and endo-crown **Time Frame:** follow up will be 3,6,9,12 month #### Secondary Outcomes **Description:** Parents' responses were rated on a 5-point Likert-type scale. **Measure:** parent's satisfaction analysis **Time Frame:** follow up will be 3,6,9,12 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1 - Parents' and patients' acceptance and cooperation 2- Apparently Healthy children. 3- Child's age ranging from 4 to 8 years old. 4- Primary 2nd molars with deep carious lesion indicated for vital Pulptomy 5- No periapical pathological lesion 6- No root resorption exceeding more than 2/3 of root length. Exclusion Criteria: 1. Medically compromised children (bleeding disorders, cardiac patient and any systemic diseases could affect oral and gingival health. 2. Presence of para-functional habits. Such bruxism, TMJ disorders 3. Non-restorable tooth. 4. Teeth with non-vital pulp **Maximum Age:** 8 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculity of Dentistry **Zip:** 02 #### Overall Officials **Official 1:** **Affiliation:** Al-Azhar University **Name:** kareem elhosary, master degree **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** after 1.5 years ## Document Section ### Large Document Module #### Large Docs - Date: 2023-02-19 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 909190 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-17T17:53 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433128 **Brief Title:** Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections **Official Title:** Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options #### Organization Study ID Info **ID:** EAP to Fosmanogepix #### Organization **Class:** INDUSTRY **Full Name:** Basilea Pharmaceutica ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** AVAILABLE **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Basilea Pharmaceutica #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication. ### Conditions Module **Conditions:** - Invasive Fungal Infections **Keywords:** - Fungal infection - Candida - Anti-fungal - Yeast - Mold - Rare mold ### Design Module #### Expanded Access Types **Individual:** True **Study Type:** EXPANDED_ACCESS ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Fosmanogepix solution for infusion, 20 mg/mL for intravenous administration **Name:** Fosmanogepix solution for infusion **Type:** DRUG #### Intervention 2 **Description:** Fosmanogepix 400 mg tablets for oral administration **Name:** Fosmanogepix 400 mg tablets **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication. **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** WEP-Clinical Pharmaceutical Services Provider **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Marc Engelhardt **Phone:** +41 79 701 0551 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M12136 - Name: Mycoses - Relevance: HIGH - As Found: Fungal Infections - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M1099 - Name: Invasive Fungal Infections - Relevance: HIGH - As Found: Invasive Fungal Infections - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000009181 - Term: Mycoses - ID: D000072742 - Term: Invasive Fungal Infections ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433115 **Brief Title:** Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome **Official Title:** Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome #### Organization Study ID Info **ID:** 2097458 #### Organization **Class:** OTHER **Full Name:** University of Missouri-Columbia #### Secondary ID Infos **Domain:** University of Missouri **ID:** 2097458 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Missouri-Columbia #### Responsible Party **Investigator Affiliation:** University of Missouri-Columbia **Investigator Full Name:** Jaapna Dhillon **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome. **Detailed Description:** The study is a 6-wk randomized, controlled, and parallel arm clinical trial. Participants will be randomized to consume either lean grain-fed beef, lean grass-fed beef, or plant-based meat for 6 weeks. Outcomes assessed will include metabolic, inflammatory, and gut microbiome markers. ### Conditions Module **Conditions:** - Diet Intervention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel Assignment ##### Masking Info **Masking:** SINGLE **Masking Description:** Single Blind **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks. **Intervention Names:** - Other: Lean (93%) Grass-Fed Beef **Label:** Lean (93%) Grass-Fed Beef **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks. **Intervention Names:** - Other: Lean (93%) Grain-Fed Beef **Label:** Lean (93%) Grain-Fed Beef **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Plant-based meat (beyond meat product) would be macronutrient matched to the same quantities of meat prescribed for a given energy level. Participants will consume meals for six weeks. **Intervention Names:** - Other: Plant-Based Meat **Label:** Plant-Based Meat **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Lean (93%) Grass-Fed Beef **Description:** The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. **Name:** Lean (93%) Grass-Fed Beef **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Lean (93%) Grain-Fed Beef **Description:** The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. **Name:** Lean (93%) Grain-Fed Beef **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Plant-Based Meat **Description:** Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level. **Name:** Plant-Based Meat **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Untargeted and targeted metabolomics **Measure:** Metabolite intensities **Time Frame:** Baseline, week 6 **Description:** 24 hours dietary recall **Measure:** Nutrient intakes **Time Frame:** Baseline, week 3, week 6 #### Primary Outcomes **Description:** Lipid profile **Measure:** LDL-C concentrations **Time Frame:** Baseline, week 6 **Description:** Inflammatory marker **Measure:** Interleukin-6 concentrations **Time Frame:** Baseline, week 6 **Description:** Assessed via16S rRNA sequencing **Measure:** Gut microbial alpha-diversity **Time Frame:** Baseline, week 6 #### Secondary Outcomes **Description:** Lipid profile **Measure:** HDL-C concentrations **Time Frame:** Baseline, week 6 **Description:** Lipid profile **Measure:** Total cholesterol concentrations **Time Frame:** Baseline, week 6 **Description:** Lipid profile **Measure:** Triglyceride concentrations **Time Frame:** Baseline, week 6 **Description:** 16S rRNA sequencing **Measure:** Gut microbiome abundance **Time Frame:** Baseline, week 6 **Description:** Intestinal permeability marker **Measure:** LPS-binding protein concentration **Time Frame:** Baseline, week 6 **Description:** Blood Glucose **Measure:** Glucose concentrations **Time Frame:** Baseline, week 6 **Description:** Insulin **Measure:** Insulin concentrations **Time Frame:** Baseline, week 6 **Description:** Measured in kg **Measure:** Body mass **Time Frame:** Baseline, week 3, and week 6 **Description:** Fat mass **Measure:** Fat mass **Time Frame:** Baseline, week 3, and week 6 **Description:** Fat-free mass **Measure:** Fat-free mass **Time Frame:** Baseline, week 3, and week 6 **Description:** Waist circumference **Measure:** Waist circumference **Time Frame:** Baseline, week 3, and week 6 **Description:** Hip Circumference **Measure:** Hip circumference **Time Frame:** Baseline, week 3, and week 6 **Description:** Thigh Circumference **Measure:** Thigh circumference **Time Frame:** Baseline, week 3, and week 6 **Description:** 24-hour appetite ratings assessed on VAS **Measure:** 24 hour appetite ratings **Time Frame:** Baseline, week 6 **Description:** Activity assessment using Actigraphs **Measure:** Physical activity scores **Time Frame:** Baseline, week 6 **Description:** Sleep diary **Measure:** Total hours of sleep **Time Frame:** Baseline, week 6 **Description:** Hedonic general labelled magnitude scale (gLMS) **Measure:** Palatability rating of foods **Time Frame:** Baseline, week 3, week 6 **Description:** 9-point food action rating scale **Measure:** Acceptance rating of foods **Time Frame:** Baseline, week 3, week 6 **Description:** Sensory intensity scales **Measure:** Taste and flavor intensity ratings of foods **Time Frame:** Baseline **Description:** Transcriptomics analyses **Measure:** Gene expression levels **Time Frame:** Baseline, week 6 **Description:** Inflammatory markers **Measure:** Inflammatory marker concentrations **Time Frame:** Baseline, week 6 **Description:** NCI diet history questionnaire **Measure:** Healthy eating index score **Time Frame:** Baseline, week 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age: 18-45 years of age * BMI: 18-35 kg/m2 * Willingness to consume study foods. * Willing to comply with study protocol. * Consistent diet and activity patterns for 4 weeks * Weight stable (≤5 kg change over the last 3 months) * Non-smoker \>1 year or more Exclusion Criteria: * Allergies to foods provided in the study * Diabetes * Gastrointestinal disease and/or bariatric surgery * Uncontrolled hypertension and blood pressure ≥ 180/110 * Illicit drug use * Recent consumption of antibiotics * Recent start of medications that affect metabolism or appetite. * Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia * Pregnant or lactating individuals * Taste or smell disorders **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jaapna Dhillon **Phone:** 573-884-2103 **Role:** CONTACT #### Locations **Location 1:** **City:** Columbia **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jaapna Dhillon - **Phone:** 573-884-2103 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jaapna Dhillon, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Missouri-Columbia **State:** Missouri **Zip:** 65211 #### Overall Officials **Official 1:** **Affiliation:** University of Missouri-Columbia **Name:** Jaapna Dhillon, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Data will be deposited in online repositories **Description:** Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices) **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Immediately following publication. No end date. ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433102 **Brief Title:** Evaluation of Visual Training System in Patients With Glaucoma **Official Title:** Assessing the Effectiveness of Visual Perception Training Based on Lateral Masking Paradigm in Glaucoma Patients #### Organization Study ID Info **ID:** 2023KYPJ008 #### Organization **Class:** OTHER **Full Name:** Zhongshan Ophthalmic Center, Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-04-26 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhongshan Ophthalmic Center, Sun Yat-sen University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study intends to conduct visual function examinations and follow-ups on two groups of glaucoma patients, one receiving visual perceptual training and the other serving as a control without training. The aim of this study is to explore the effects of visual perceptual training based on the lateral masking paradigm on patients' visual function. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in patients' visual function are accompanied by corresponding alterations in brain function. **Detailed Description:** Glaucoma is a chronic eye disease that causes irreversible damage to the optic nerve and can lead to severe vision loss and blindness. In China, the blindness rate among glaucoma patients is 22.7%, accounting for 8.8% of the total blind population. Among individuals aged 40 and above in urban and rural areas of China, approximately 9.2 million suffer from glaucoma, with 55% experiencing blindness in at least one eye and 18.1% experiencing blindness in both eyes \[1,2\]. Glaucoma patients may experience severe impairment in visual function, leading to significant limitations in vision-related activities such as mobility and visual searching. This has a negative impact on the quality of life (QOL) of patients, increasing the burden on individuals, families, and society. Vision Rehabilitation (VR) is an integral component of the eye care continuum, spanning from diagnosis to treatment and rehabilitation \[3\]. It aims to assist visually impaired patients in maximizing their remaining vision, facilitating easier performance of daily activities, promoting independence, and enhancing quality of life (QOL). However, for glaucoma patients with visual field defects, traditional methods such as inverted telescopes and prism glasses are plagued by shortcomings such as unattractive appearance, bulkiness, blurred visual quality, and challenges in adaptation. Perceptual Learning (PL) is a novel rehabilitation approach aimed at enhancing visual performance through intensified practice of visual tasks. Many studies have shown that visual perceptual training can improve visual function in patients with different types of amblyopia or presbyopia, as the nervous system exhibits significant neuroplasticity \[4-6\]. However, there is limited research on visual perceptual training in visual rehabilitation for glaucoma. Therefore, this study intends to conduct visual function examinations and follow-ups on two groups of glaucoma patients, one receiving visual perceptual training and the other serving as a control without training. The aim of this study is to explore the effects of visual perceptual training based on the lateral masking paradigm on patients' visual function. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in patients' visual function are accompanied by corresponding alterations in brain function. ### Conditions Module **Conditions:** - Glaucoma **Keywords:** - Visual perceptual training - Vision rehabilitation - Glaucoma - Lateral masking paradigm ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** randomized controlled trial ##### Masking Info **Masking:** SINGLE **Masking Description:** The technical staff and research assistants involved in subject enrollment, outcome measurement, and data collection are blinded to the intervention allocation. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this group received visual perceptual training based on the lateral masking paradigm every other day for 35 to 45 minutes, with each cycle consisting of 40 sessions, lasting approximately 3 months. The training began in the hospital during the first week and continued at home using personal computers thereafter. The personal computers were connected to a central server via the internet. **Intervention Names:** - Other: Visual perceptual training based on the lateral masking paradigm **Label:** the training group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group maintained the original treatment plan without any additional interventions. **Label:** the control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - the training group **Description:** Visual perceptual training is a novel rehabilitation approach aimed at enhancing visual performance through practice of visual tasks. Patients received visual perceptual training based on the lateral masking paradigm every other day. Each training session consisted of 9 stages, totaling 900 trials, lasting 35 to 45 minutes. The stimuli consisted of a central Gabor patch with relatively low contrast positioned in the central fixation area, along with co-linear high-contrast Gabor patches distributed above and below the central stimulus. These stimuli were presented on a Liquid Crystal Display (LCD) monitor, with a training distance of 150 cm. **Name:** Visual perceptual training based on the lateral masking paradigm **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Contrast sensitivity function (CSF) was assessed using the qCSF method at baseline, and at 1 day, 3 months, and 6 months after the intervention. The qCSF method employed a Bayesian adaptive learning procedure. Data collected for analysis included contrast sensitivity at 19 spatial frequencies, the area under the log CSF (AULCSF), and the cutoff spatial frequency. **Measure:** Contrast sensitivity function **Time Frame:** 6 months after intervention #### Secondary Outcomes **Description:** Visual field testing was conducted using automated perimetry with the 30-2 Swedish interactive threshold algorithm. The examination was performed at baseline and 1 day, 3 months, and 6 months after the intervention. **Measure:** Visual field **Time Frame:** 6 months after intervention **Description:** Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart was used. The examination was performed at baseline and 1 day, 3 months, and 6 months after the intervention. **Measure:** Visual acuity **Time Frame:** 6 months after intervention **Description:** Stereoacuity was measured using the Titmus stereopsis test at baseline, as well as 1 day, 3 months, and 6 months after the intervention. **Measure:** Stereoacuity **Time Frame:** 6 months after intervention **Description:** The GVFQ-40 consists of 40 items and measures the difficulty of daily activities of glaucoma patients in five domains of functioning (mobility, visual tracking, reading, identification and night vision ). Each item has six answer options, that is, no difficulty (score = 1), mild difficulty (score = 2), moderate difficulty (score = 3), extremely difficult (score = 4), completely unable to complete (score = 5), and do not perform for nonvisual reasons (no score). The GVFQ-40 was administered at baseline and 1 day, 3 months, and 6 months after the intervention. **Measure:** Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40) **Time Frame:** 6 months after intervention **Description:** The National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) is a valid and reliable vision-related quality of life (QOL) questionnaire designed for persons who have chronic eye diseases or low vision. It includes 25 items that comprise 11 subscales on different aspects of vision-related functioning and QOL and 1 item on general health. NEI VFQ-25 scores range from 0 to 100, with a higher score representing better functioning. The NEI VFQ-25 was administered at baseline and 1 day, 3 months, and 6 months after the intervention. **Measure:** National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) **Time Frame:** 6 months after intervention **Description:** The reaching-and-grasping (prehension) task was conducted to assess patients' eye-hand coordination abilities at baseline and 1 day, 3 months, and 6 months post-intervention. The motion capture system recorded the movements of the preferred hand. Various metrics of prehension planning and online control were measured, including initiation time, total movement duration, peak velocity, and other relevant parameters. **Measure:** Reach-and-Grasp Kinematics **Time Frame:** 6 months after intervention **Description:** Electroencephalogram was performed to track the electrical activity of the brain in real time at baseline and 1 day, 3 months, and 6 months after the intervention. Node efficiency was calculated. Node efficiency is a metric that characterizes the efficiency of a single node in connecting with all other parts of the network. It reflects the centrality and importance of a node within the network. **Measure:** Electroencephalogram (EEG) node efficiency **Time Frame:** 6 months after intervention **Description:** Functional near-infrared spectroscopy (fNIRS) was conducted to capture spatial information on cerebral blood flow and oxygenation conditions at baseline, as well as 1 day, 3 months, and 6 months after the intervention. **Measure:** Functional near-infrared spectroscopy (fNIRS) **Time Frame:** 6 months after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. age ≥ 10 years old 2. diagnosed with primary glaucoma or developmental glaucoma 3. the best corrected visual acuity ≥0.1 and the mean deviation of the visual field worse or equal to -6 dB 4. visual acuity, intraocular pressure, and other eye conditions have been stable for more than 3 months 5. participants capable of understanding the purpose of the study and providing informed consent 6. participants capable of cooperating with relevant examinations. Exclusion Criteria: 1. a history of eye surgery or eye laser within three months 2. complicated with other ophthalmopathy affecting visual function (except cataract, ametropia), such as age-related macular degeneration, diabetic retinopathy, optic nerve disease, retinal vascular disease, etc. 3. serious systemic diseases, such as neurological diseases, cardiovascular diseases, psychological diseases, malignant tumors, etc 4. pregnant or lactating women. **Healthy Volunteers:** True **Minimum Age:** 10 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** Zhongshan Opthalmic Center, Sun Yat-sen University **State:** Guangdong **Zip:** 510060 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Foster PJ, Johnson GJ. Glaucoma in China: how big is the problem? Br J Ophthalmol. 2001 Nov;85(11):1277-82. doi: 10.1136/bjo.85.11.1277. **PMID:** 11673287 **Citation:** Fontenot JL, Bona MD, Kaleem MA, McLaughlin WM Jr, Morse AR, Schwartz TL, Shepherd JD, Jackson ML; American Academy of Ophthalmology Preferred Practice Pattern Vision Rehabilitation Committee. Vision Rehabilitation Preferred Practice Pattern(R). Ophthalmology. 2018 Jan;125(1):P228-P278. doi: 10.1016/j.ophtha.2017.09.030. Epub 2017 Nov 4. No abstract available. **PMID:** 29108747 **Citation:** Matteo BM, Vigano B, Cerri CG, Perin C. Visual field restorative rehabilitation after brain injury. J Vis. 2016 Jul 1;16(9):11. doi: 10.1167/16.9.11. **PMID:** 27472498 **Citation:** Polat U, Ma-Naim T, Belkin M, Sagi D. Improving vision in adult amblyopia by perceptual learning. Proc Natl Acad Sci U S A. 2004 Apr 27;101(17):6692-7. doi: 10.1073/pnas.0401200101. Epub 2004 Apr 19. **PMID:** 15096608 **Citation:** Zhong J, Wang W, Li J, Wang Y, Hu X, Feng L, Ye Q, Luo Y, Zhu Z, Li J, Yuan J. Effects of Perceptual Learning on Deprivation Amblyopia in Children with Limbal Dermoid: A Randomized Controlled Trial. J Clin Med. 2022 Mar 28;11(7):1879. doi: 10.3390/jcm11071879. **PMID:** 35407483 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009798 - Term: Ocular Hypertension - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M9013 - Name: Glaucoma - Relevance: HIGH - As Found: Glaucoma - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M12731 - Name: Ocular Hypertension - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005901 - Term: Glaucoma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433089 **Brief Title:** Postoperative Pain for Patients After TA-BSM **Official Title:** Effect of Thoracic Paravertebral Nerve Block on Postoperative Pain After Transapical Beating-heart Myectomy(TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy: a Retrospective Cohort Study #### Organization Study ID Info **ID:** TJMZK230601 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-30 **Type:** ACTUAL #### Start Date **Date:** 2023-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-11 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wenlong Yao (101480) #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Wenlong Yao (101480) **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To retrospectively analyze the intraoperative and postoperative status of patients with hypertrophic cardiomyopathy undergoing TA-BSM, and to estimate whether paravertebral nerve block can improve postoperative pain for these patients. **Detailed Description:** Since conventional septal myectomy can be only assessed when the heart resumes beating, and the complications induced by cardiopulmonary bypass are inevitable, a novel transapical beating-heart septal myectomy (TA-BSM) has been invented, which provides real-time evaluation to guide resection while reducing surgical trauma. Postoperative pain after TA-BSM is unknown. Whether paravertebral nerve block can improve postoperative pain caused by TA-BSM is the objective of our study. ### Conditions Module **Conditions:** - Nerve Block - Transapical Beating-heart Septal Myectomy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 197 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patients received General Anesthesia(GA) combined with Paravertebral Block(PVB). **Intervention Names:** - Procedure: Thoracic paravertebral block **Label:** group GA+PVB #### Arm Group 2 **Description:** The patients received general anesthesia only. **Label:** group GA only ### Interventions #### Intervention 1 **Arm Group Labels:** - group GA+PVB **Description:** Thoracic paravertebral block was performed before surgery **Name:** Thoracic paravertebral block **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Cumulative morphine consumption **Measure:** Morphine consumption **Time Frame:** During the first 48 hours after surgery #### Secondary Outcomes **Description:** Visual Analogue Scale score(0-10 stands for the degree of pain, 0=no pain, 10=the worst pain ever) **Measure:** Postoperative pain score 1 **Time Frame:** 24 hours after surgery and and 48 hours after surgery **Description:** Brief Pain Inventory(The degree of pain \[0 no pain to 10 very painful\] and the impact of pain on daily life function \[0 no impact to 10 very impact\]) **Measure:** Postoperative pain score 2 **Time Frame:** Day 7 after surgery and month 3 after surgery **Description:** Quality of recovery(Rating from 0 \[very poor\] to 150 \[excellent\]) **Measure:** Physical recovery after surgery **Time Frame:** Day 7 after surgery **Description:** The incidence of nausea and vomiting **Measure:** Complications **Time Frame:** 24 hours and 48 hours after surgery **Description:** The usage of analgesic drug **Measure:** Perioperative information 1 **Time Frame:** Immediately after the surgery **Description:** Mean arterial blood pressure **Measure:** Perioperative information 2 **Time Frame:** P1= before induction, P2= 5 minutes after tracheal intubation, P3= before skin incision, P4= 5 minutes after skin incision, P5=5 minutes after placed the rib spreader **Description:** Heart reat **Measure:** Perioperative information 3 **Time Frame:** P1= before induction, P2= 5 minutes after tracheal intubation, P3= before skin incision, P4= 5 minutes after skin incision, P5=5 minutes after placed the rib spreader **Description:** Duration of anesthesia **Measure:** Perioperative information 4 **Time Frame:** Immediately after the surgery **Description:** Extubation time **Measure:** Postoperative information 1 **Time Frame:** Postoperative in 24 hours **Description:** The usage of analgesic drug **Measure:** Postoperative information 2 **Time Frame:** Postoperative in 48 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18\~75 years * American society of anesthesiologists classification II-III * Elective TA-BSM was performed Exclusion Criteria: * Underwent multiple surgical procedures or required cardiopulmonary bypass assistance * Combined other function decompensation disease * Patients with incomplete medical records **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The information of all patients with hypertrophic cardiomyopathy undergoing TA-BSM in our hospital from April 2023 to September 2023 was extracted and screened according to the inclusion criteria and exclusion criteria. ### Contacts Locations Module #### Locations **Location 1:** **City:** Wuhan **Country:** China **Facility:** Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University **State:** Hubei **Zip:** 430030 #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital **Name:** Wenlong Yao **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M10035 - Name: Hypertrophy - Relevance: LOW - As Found: Unknown - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M12154 - Name: Cardiomyopathies - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433076 **Acronym:** EFFORT-1 **Brief Title:** The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients: A Prospective Observational Study. **Official Title:** The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients: A Prospective Observational Study. #### Organization Study ID Info **ID:** COA. MURA2022/317 #### Organization **Class:** OTHER **Full Name:** Ramathibodi Hospital ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-31 **Type:** ACTUAL #### Start Date **Date:** 2022-06-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ramathibodi Hospital #### Responsible Party **Investigator Affiliation:** Ramathibodi Hospital **Investigator Full Name:** Phruet Soipetkasem **Investigator Title:** Critical care medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Over-assisted mechanical ventilation (MV) is linked to respiratory muscle disuse atrophy, while under-assisted MV can lead to patient self-inflicted lung injury (P-SILI) or respiratory muscle injuries. Both scenarios result in poor outcomes. This hypothesis aims to demonstrate the association between the degree of respiratory effort which was measured by P0.1, predicted Pmus, and predicted Δtranspulmonary pressure (ΔPL) with ventilator-free days (VFD) and 28-day mortality. **Detailed Description:** Recently, the lung and diaphragm protective strategy is an important consideration when providing mechanical ventilation to critically ill patients. Although mechanical ventilation can be life-saving, improper management can cause harm. The harmful mechanical ventilator setting can result from over-assisted or under-assisted ventilation. Over-assisted ventilation can be caused by too much ventilatory support or calming down patients with high dosages of sedative drugs or muscle relaxants, which negatively affect the operation of the diaphragm leading to diaphragm muscle atrophy and weakness. This can make it more difficult to weaning and lead to prolonged use of mechanical ventilation. It appears that previous study found a correlation between percentage change in diaphragm thickness fraction, as measured by ultrasound, during the first week of mechanical ventilation and prolonged duration of mechanical ventilation, extended length of stay in the ICU, and complications. Additionally, in the study conclusions, a diaphragm thickness fraction of 15-30% during the first three days of mechanical ventilation was associated with the shortest duration of mechanical ventilation and this may potentially help guide the management of respiratory support. On the other hand, the effect of under-assist breathing or allowing excessive respiratory effort could be harmful. Some reported in chronic obstructive pulmonary disease (COPD) exacerbation patients found that the increased negative intra-thoracic pressure potentially causes injury to the diaphragm sarcomeres, which are the muscle fibers responsible for generating force during breathing and it was proportional to the degree of obstruction. And compared light microscopy of the diaphragmatic muscles necropsy in patients who died of COPD with normal subjects. They found muscular necrosis and accumulation of fibrosis and collagen deposits. The cytoplasm was scattered, disrupted, and lipofuscin accumulation with hyper-eosinophilia was observed. In addition, an excessive high respiratory effort can cause lung injury by patient-self known as patient self-inflicted lung injury (P-SILI), a theory first mentioned that the increased magnitude of negative intrathoracic pressure during inhalation may cause the fluid shift from the pulmonary capillaries to the alveoli causing pulmonary edema. This is relevant to the observational studies that the occurrence of negative intrathoracic pressure during large inhalations in obstruction airway patients, such as tracheal stenosis, also results in pulmonary edema. In latterly confirmed this hypothesis. Subsequent studies have supported this phenomenon and overall could be explained through the increase of transpulmonary pressure, pendelluft phenomenon and patient-ventilator asynchrony (PVA). However, no current studies determine the relationship between respiratory effort measurement during mechanical ventilation and clinical outcomes. Therefore, we conduct the study to determine the relationship between respiratory effort parameters and clinical outcomes. ### Conditions Module **Conditions:** - Respiratory Effort - Respiratory Distress Syndrome - Lung Mechanics **Keywords:** - Respiratory effort - Acute respiratory distress syndrome (ARDS) - Dynamic transpulmonary pressure swing (Predicted ΔPL) - Patient self-inflicted lung injury (P-SILI) - Patient ventilator asynchrony (PVA) ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 163 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The preference respiratory effort group was defined by either 1.5≤P0.1≤3.5 cmH2O, 5≤ predicted Pmus≤10 cmH2O, or predicted ΔPL≤20 cmH2O. **Label:** Preference respiratory effort #### Arm Group 2 **Description:** The insufficiency respiratory effort group was defined by either P0.1\<1.5 cmH2O or predicted Pmus \< 5 cmH2O. **Label:** Insufficiency respiratory effort #### Arm Group 3 **Description:** The excessive respiratory effort group was defined by either P0.1 \> 3.5 cmH2O, predicted Pmus \> 10 cmH2O, or predicted ΔPL \> 20 cmH2O. **Label:** Excessive respiratory effort ### Outcomes Module #### Primary Outcomes **Description:** The number of VFDs was defined as the number of days from the last day of mechanical ventilation to day 28. If a patient died during the first 28 days, their number of VFDs is equal to zero. **Measure:** 28 days ventilator-free days (VFDs) **Time Frame:** After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days. #### Secondary Outcomes **Description:** Short-term mortality was defined as death occurring within 28 days from the start of enrollment, documented as either alive or deceased 28 days after intubation. **Measure:** 28 days all-cause mortality **Time Frame:** After intubated patients were recruited until alive or dead with in 28 days. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participants must be aged between 18-75 years. 2. Admitted to the critical care and semi-critical care units (ICUs) of the Department of -Internal Medicine, Ramathibodi Hospital (ICUs 9IC, 8IK, and 7NW). 3. Patients with acute respiratory failure admitted to the hospital with the following conditions within the first 48 hours: * PaO2/FiO2 greater than 150 or * PaO2 less than 60 mm Hg or * SaO2 less than 90 mm Hg or * Work of breathing more than 25 breaths per minute or requiring respiratory muscle assistance 4. Permission obtained from the attending physician. 5. Research participants or their direct relatives must sign informed consent. 6. The research can commence and data can be recorded within 48 hours after the patient has received treatment with the mechanical ventilator. Exclusion Criteria: 1. Admitted to the hospital or had a history of hospital admission within a month before recruitment. 2. History of cardiovascular or cerebrovascular events within the last 12 months. 3. Pregnant. 4. Terminal-stage cancer patient, terminal illness-stage of disease who desire palliative care. 5. Active neurological or muscular disorders affecting stability. 6. Brain coma, brain death, or status epilepticus. 7. Severe mental health conditions, including active depression with psychotic features, bipolar disorder, or schizophrenia. 8. Uncontrolled thyroid conditions within a month before recruitment. 9. Uncorrectable patients with severe hypoxemia (P/F ratio less than 150). 10. Patients receiving neuromuscular blocking agents. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A single-center analytical observational prospective study was conducted between June 2022 and April 2024. We enrolled acute respiratory failure patients who required mechanical ventilation from the intensive care units (ICUs) at Ramathibodi Hospital, Mahidol University. ### Contacts Locations Module #### Locations **Location 1:** **City:** Bangkok **Country:** Thailand **Facility:** Mr. Phruet Soipetkasem **Zip:** 10400 #### Overall Officials **Official 1:** **Affiliation:** Doctor of Critical care medicine Ramathibodi hospital **Name:** Mr. Phruet Soipetkasem, Critical care doctor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Head of Critical care medicine Ramathibodi hospital **Name:** Pongdhep Theerawit, Assoc. Prof. **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Clinical professor of Pulmonary and Critical care medicine Ramathibodi hospital **Name:** Yuda Sutherasan, Assoc. Prof. **Role:** STUDY_DIRECTOR **Official 4:** **Affiliation:** Clinical professor of Pulmonary and Critical care medicine Ramathibodi hospital **Name:** Mr. Detajin Junhasavasdikul, Asst.Prof. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC. **PMID:** 27626706 **Citation:** Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC. **PMID:** 28930478 **Citation:** Orozco-Levi M, Lloreta J, Minguella J, Serrano S, Broquetas JM, Gea J. Injury of the human diaphragm associated with exertion and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1734-9. doi: 10.1164/ajrccm.164.9.2011150. **PMID:** 11719318 **Citation:** Scott A, Wang X, Road JD, Reid WD. Increased injury and intramuscular collagen of the diaphragm in COPD: autopsy observations. Eur Respir J. 2006 Jan;27(1):51-9. doi: 10.1183/09031936.06.00143004. **PMID:** 16387935 **Citation:** Loeb L. The Mechanism in the Development of Pulmonary Edema. Proceedings of the Society for Experimental Biology and Medicine. 1928;25(5):321-323. doi:10.3181/00379727-25-3837 **Citation:** Moore RL, Binger CA. THE RESPONSE TO RESPIRATORY RESISTANCE : A COMPARISON OF THE EFFECTS PRODUCED BY PARTIAL OBSTRUCTION IN THE INSPIRATORY AND EXPIRATORY PHASES OF RESPIRATION. J Exp Med. 1927 May 31;45(6):1065-80. doi: 10.1084/jem.45.6.1065. **PMID:** 19869306 **Citation:** Barach AL, Eckman M. THE EFFECTS OF INHALATION OF HELIUM MIXED WITH OXYGEN ON THE MECHANICS OF RESPIRATION. J Clin Invest. 1936 Jan;15(1):47-61. doi: 10.1172/JCI100758. No abstract available. **PMID:** 16694380 **Citation:** Dreyfuss D, Soler P, Basset G, Saumon G. High inflation pressure pulmonary edema. Respective effects of high airway pressure, high tidal volume, and positive end-expiratory pressure. Am Rev Respir Dis. 1988 May;137(5):1159-64. doi: 10.1164/ajrccm/137.5.1159. **PMID:** 3057957 **Citation:** Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972. **PMID:** 23263584 **Citation:** Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0. **PMID:** 31694692 **Citation:** Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D. Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14. doi: 10.1007/BF00255628. **PMID:** 3230208 **Citation:** Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC. **PMID:** 24199628 **Citation:** Dzierba AL, Khalil AM, Derry KL, Madahar P, Beitler JR. Discordance Between Respiratory Drive and Sedation Depth in Critically Ill Patients Receiving Mechanical Ventilation. Crit Care Med. 2021 Dec 1;49(12):2090-2101. doi: 10.1097/CCM.0000000000005113. **PMID:** 34115638 **Citation:** Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22. **PMID:** 27334266 **Citation:** Loring SH, O'Donnell CR, Behazin N, Malhotra A, Sarge T, Ritz R, Novack V, Talmor D. Esophageal pressures in acute lung injury: do they represent artifact or useful information about transpulmonary pressure, chest wall mechanics, and lung stress? J Appl Physiol (1985). 2010 Mar;108(3):515-22. doi: 10.1152/japplphysiol.00835.2009. Epub 2009 Dec 17. **PMID:** 20019160 **Citation:** Baedorf Kassis E, Loring SH, Talmor D. Mortality and pulmonary mechanics in relation to respiratory system and transpulmonary driving pressures in ARDS. Intensive Care Med. 2016 Aug;42(8):1206-13. doi: 10.1007/s00134-016-4403-7. Epub 2016 Jun 18. **PMID:** 27318943 **Citation:** Taran Z, Namadian M, Faghihzadeh S, Naghibi T. The Effect of Sedation Protocol Using Richmond Agitation-Sedation Scale (RASS) on Some Clinical Outcomes of Mechanically Ventilated Patients in Intensive Care Units: a Randomized Clinical Trial. J Caring Sci. 2019 Dec 1;8(4):199-206. doi: 10.15171/jcs.2019.028. eCollection 2019 Dec. **PMID:** 31915621 ## Document Section ### Large Document Module #### Large Docs - Date: 2023-06-08 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 166863 - Type Abbrev: ICF - Upload Date: 2024-05-25T23:13 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012120 - Term: Respiration Disorders - ID: D000007235 - Term: Infant, Premature, Diseases - ID: D000007232 - Term: Infant, Newborn, Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14965 - Name: Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M14964 - Name: Respiratory Distress Syndrome, Newborn - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M28144 - Name: Acute Lung Injury - Relevance: LOW - As Found: Unknown - ID: M28143 - Name: Lung Injury - Relevance: LOW - As Found: Unknown - ID: M3385 - Name: Patient-Ventilator Asynchrony - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M10279 - Name: Infant, Premature, Diseases - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: T4927 - Name: Respiratory Distress Syndrome, Infant - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: T192 - Name: Acute Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012128 - Term: Respiratory Distress Syndrome - ID: D000012127 - Term: Respiratory Distress Syndrome, Newborn ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433063 **Acronym:** LuMISO **Brief Title:** Effect of Hypoxia on FMISO PET to Response to Lu-177 PSMA Treatment **Official Title:** Effect of 18F-Fluoromisonidazole (18F-FMISO) PET Imaging on Evaluation of Hypoxia Before Lu-177 PSMA Treatment for Prostate Cancer #### Organization Study ID Info **ID:** LuMISO #### Organization **Class:** OTHER **Full Name:** Ankara University ### Status Module #### Completion Date **Date:** 2026-02-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cigdem Soydal #### Responsible Party **Investigator Affiliation:** Ankara University **Investigator Full Name:** Cigdem Soydal **Investigator Title:** Asc Prof of Nuclear Medicine **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** It is aimed to evaluate hypoxia before Lu-177 PSMA treatment in prostate cancer and to show its effect on treatment success with 18F-FMISO PET imaging, which allows in-vivo evaluation and quantification of tumor hypoxia, which is known to be one of the factors affecting radiotherapy resistance. **Detailed Description:** Prostate cancer is the second most common cancer in men and the fifth leading cause of cancer-related deaths. 20% of patients diagnosed with prostate cancer have metastatic disease, and survival rates of more than 5 years have been reported in only 26-30% of them. Androgen deprivation therapy (ADT) is the main treatment method used for years in the treatment of prostate cancer. However, a high rate of resistance develops to this treatment and becomes castration-resistant prostate cancer. Castration-resistant prostate cancer (CRPC) is defined as an increase in PSA levels, clinical or radiological progression, or the emergence of new distant metastases despite lowering serum testosterone to castration levels. FDA-approved drugs such as Sipuleucel-T, Docetaxel, Cabazitaxel, Abireterone, Enzalutamide, Radium-223, Rucaparib, and Olaparib have been shown to increase overall survival in mKDPK. Although there are many treatment classes that delay disease progression and increase survival, mKDPK remains incurable and fatal. Radionuclide therapy (Lu-177 PSMA) has emerged as a promising treatment in patients resistant to these treatments. Although some criteria have been defined to select patients who will benefit from treatment based on parameters such as SUVmax, some of the patients do not respond to radionuclide treatments, and PSA response can be achieved in only a little more than half of the patients in Lu-177 PSMA treatment, which stands out as one of the most effective therapies. The role of hypoxia, which is one of the possible factors affecting the treatment response other than PSMA avidity, in the success of Lu-177 PSMA treatment is currently unclear. Radiation damage causing cell apoptosis and necrosis occurs through mechanisms such as ionizing radiation causing single or double chain breaks and creating reactive oxygen compounds in surrounding molecules. It is known that hypoxia causes radiotherapy resistance by preventing the formation of reactive oxygen compounds in tumors. 18F-Fluoromisonidazole (18F-FMISO) is an 18F-labelled PET radiopharmaceutical, like 18F-FDG, which has a half-life of 110 minutes and is frequently used in clinical practice. 18F-FMISO is a nitroimidazole class compound known to accumulate in hypoxic cells. After entering viable cells, 18F-FMISO is reduced to the RNO2 radical. In the presence of oxygen, 18F-FMISO can be oxidized again and freely exit the cell. However, since re-oxidation is not possible in hypoxic cells, 18F-FMISO is trapped in hypoxic but viable cells. It has previously been shown that it is possible to predict radiotherapy response with 18F-FMISO PET imaging in malignancies such as head-neck and lung cancers and the feasibility of personalized treatment according to hypoxia demonstrated with 18F-FMISO. In a study, the presence of hypoxia was demonstrated with 18F-FMISO PET in high-grade tumors in patients receiving neoadjuvant ADT, and hypoxia was shown to regress with tumor response. However, to our knowledge, there is no study yet for Lu-177 PSMA treatment, which is one of the most important internal radiotherapies in prostate cancer. In this study, it was aimed to quantify hypoxia in primary tumors and metastases of prostate cancer with 18F-FMISO and to show its effect on treatment resistance. Patients referred for Lu-177 PSMA treatment and found suitable for treatment will be included in the study. Within 4 weeks before Lu-177 PSMA treatment, patients will undergo PET imaging after 18F-FMISO injection and SUVmax, SUVmean, metabolic tumor volume and total 18F-FMISO retention parameters will be obtained from the tumors. Following this, patients will receive Lu-177 PSMA treatment in 4 cycles at 6-8 week intervals, as applied in standard clinical practice. Treatment response will be evaluated with Ga68 PSMA PET images taken after 4 cures of Lu-177 PSMA treatment. With 18F-FMISO findings, no changes will be made in the treatment process of the patients, and no additional imaging or examination will be performed after the treatment, other than routine clinical practice. ### Conditions Module **Conditions:** - Prostatic Neoplasms - Hypoxia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Metastatic castration resistant prostate cancer patients who will receive Lu-177 PSMA radionuclide treatment ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who underwent FMISO PET imaging before Lu-177 PSMA radionuclide treatment for CRPC **Intervention Names:** - Diagnostic Test: F-MISO PET **Label:** Treatment arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment arm **Description:** Evaluation of tumor hypoxia with F-MISO PET **Name:** F-MISO PET **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Evaluation of the effect of tumor hypoxia to PSA response after Lu-177 PSMA treatment **Measure:** To evaluate tumor hypoxia with F-MISO PET to PSA response **Time Frame:** 6. month after radionuclide treatment **Description:** Evaluation of the effect of tumor hypoxia to radiological response with RECIST criteria after Lu-177 PSMA treatment **Measure:** To evaluate tumor hypoxia with F-MISO PET to radiological response **Time Frame:** 6. month after radionuclide treatment **Description:** Evaluation of the effect of tumor hypoxia to PSMA response with RECIP criteria after Lu-177 PSMA treatment **Measure:** To evaluate tumor hypoxia with F-MISO PET to PSMA PET response **Time Frame:** 6. month after radionuclide treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * over 18 years old * Patients diagnosed with prostate cancer who were referred to our clinic for Lu-177 PSMA treatment and were found suitable for treatment Exclusion Criteria: * Has a life expectancy of less than 3 months * ECOG\>2 * contraindication for radionuclide treatment with Lu-177 PSMA **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cigdem Soydal, Asc Prof **Phone:** +903125956732 **Role:** CONTACT **Contact 2:** **Name:** Ecenur Dursun, Res Ass **Phone:** +903125956732 **Role:** CONTACT #### Locations **Location 1:** **City:** Ankara **Contacts:** ***Contact 1:*** - **Name:** Cigdem Soydal - **Role:** CONTACT **Country:** Turkey **Facility:** Ankara University Medical School **Status:** RECRUITING **Zip:** 06580 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012818 - Term: Signs and Symptoms, Respiratory - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostatic Neoplasms - ID: M4185 - Name: Hypoxia - Relevance: HIGH - As Found: Hypoxia - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms - ID: D000000860 - Term: Hypoxia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433050 **Acronym:** SOTA-CROSS HCM **Brief Title:** Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy **Official Title:** Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy #### Organization Study ID Info **ID:** 855065 #### Organization **Class:** OTHER **Full Name:** University of Pennsylvania #### Secondary ID Infos **ID:** R61HL164376 **Link:** https://reporter.nih.gov/quickSearch/R61HL164376 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Heart, Lung, and Blood Institute (NHLBI) #### Lead Sponsor **Class:** OTHER **Name:** University of Pennsylvania #### Responsible Party **Investigator Affiliation:** University of Pennsylvania **Investigator Full Name:** Sharlene Day **Investigator Title:** Associate Professor of Cardiovascular Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are: 1. Will sotagliflozin be well tolerated in patients with nonobstructive HCM? 2. Will sotaglifozin improve exercise capacity, diastolic dysfunction and/or physical functioning in patients with nonobstructive HCM? 3. Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM? Researchers will compare sotagliflozin to a placebo (a look-alike substance that contains no drug) to see if sotagliflozin is effective at treating hypertrophic cardiomyopathy (HCM). Participants will: Take sotagliflozin or a placebo every day for 12 weeks. They will then cross-over (or switch) to taking placebo or sotagliflozin (whichever one they did not take initially) for an additional 12 weeks. Visit the clinic once every 4-12 weeks for checkups, surveys, and tests including a stress test and echocardiogram. ### Conditions Module **Conditions:** - Hypertrophic Cardiomyopathy Without Obstruction ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Double-blinded **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 26 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Matching placebo once daily will be administered in the first phase, Sotagliflozin 400 mg once daily will be administered in the second phase **Intervention Names:** - Drug: Sotagliflozin **Label:** Placebo first phase, Sotagliflozin second phase **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Sotagliflozin 400 mg once daily will be administered in the first phase, matching placebo once daily will be administered in the second phase **Intervention Names:** - Drug: Sotagliflozin **Label:** Sotagliflozin first phase, Placebo second phase **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Placebo first phase, Sotagliflozin second phase - Sotagliflozin first phase, Placebo second phase **Description:** Sotagliflozin or placebo will be administered to each participant in a cross over study design. Each participant will receive active drug and placebo with randomization of the order in which they receive them. **Name:** Sotagliflozin **Other Names:** - Inpefa **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Adverse event reporting **Measure:** Number of participants with treatment-related adverse events **Time Frame:** Through study completion, 28 weeks **Description:** Intracavitary left ventricular pressure gradient in mmHg **Measure:** Intracavitary obstruction **Time Frame:** Through study completion, 28 weeks **Description:** New occurrence of cardiac arrhythmia measured by ambulatory monitoring **Measure:** Cardiac rhythm **Time Frame:** Through study completion, 28 weeks **Description:** Peak oxygen consumption in mL/min **Measure:** Maximal exercise capacity **Time Frame:** Through study completion, 28 weeks **Description:** Stroke volume augmentation at exercise steady state in mL/min **Measure:** Submaximal exercise capacity **Time Frame:** Through study completion, 28 weeks #### Secondary Outcomes **Description:** Left ventricular ejection fraction in % measured by echocardiography **Measure:** Systolic function **Time Frame:** Through study completion, 28 weeks **Description:** Global longitudinal strain in % measured by echocardiography **Measure:** Contractility **Time Frame:** Through study completion, 28 weeks **Description:** E/E' ratio measured by echocardiography **Measure:** Diastolic function **Time Frame:** Through study completion, 28 weeks **Description:** Maximal left ventricular wall thickness in mm by echocardiography **Measure:** Left ventricular hypertrophy **Time Frame:** Through study completion, 28 weeks **Description:** Kansas City Living with Heart Failure (KCCQ) Clinical Summary Score, scale 0-100 with lower scores being worse **Measure:** Symptom scores **Time Frame:** Through study completion, 28 weeks **Description:** Kansas City Living with Heart Failure (KCCQ) Overall Summary Score, score 0-100 with lower scores being worse **Measure:** Symptom scores and quality of life **Time Frame:** Through study completion, 28 weeks **Description:** Serum levels of N-terminal-proBNP **Measure:** Biomarkers **Time Frame:** Through study completion, 28 weeks **Description:** Concentration of serum metabolites **Measure:** Circulating metabolites **Time Frame:** Through study completion, 28 weeks **Description:** Daily step counts by actigraphy **Measure:** Measurement of periods of activity and rest **Time Frame:** Through study completion, 28 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age at least 18 years, both sexes 2. Provision of signed and dated informed consent form 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. Ability to take oral medication and be willing to adhere to the study intervention. 5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of administration of study drug. 6. Diagnosis of HCM with NYHA Class II-III functional class or New York Heart Association (NYHA) Class I with peak VO2 \< 90% on cardiopulmonary exercise stress testing performed at Visit 1. 7. Left ventricular outflow tract gradient \< 50 mmHg at rest, with valsalva, and with exercise. 7. Left ventricular ejection fraction \> 50% by echocardiogram or cardiac MRI based on the most recent assessment in the past year prior to screening and confirmed during Visit 1 echocardiogram. 8. Stable medical therapy for at least 1 month prior to study enrollment. Exclusion Criteria: 1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor 2. Type 1 diabetes mellitus 3. Age \<18 years old 4. Pregnant or lactating women: Women of childbearing potential will undergo a urine pregnancy test during the screening visit. 5. Uncontrolled atrial fibrillation, as defined by a resting heart rate \> 100 beats per minute at the time of the baseline assessment 6. Paroxysmal atrial fibrillation (Afib) or flutter with plans to attempt to restore sinus rhythm (with drug therapy, ablation, or DC cardioversion) during the study period. 7. Unable to attain a respiratory exchange ratio of at least 1.05 on cardiopulmonary exercise test (CPET) on the day of screening. 8. Septal reduction therapy within the previous 3 months. 9. Implantable cardio-defibrillator (ICD) implantation planned during the study period. 10. Implantation of a cardiac resynchronization therapy (CRT) device within 12 weeks prior to enrollment or intent to implant a CRT device during the study period 11. Hemoglobin \< 10 g/dL 12. Estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73m\^2, or unstable or rapidly progressing renal disease at the time of randomization 13. Subject inability/unwillingness to exercise 14. Greater than moderate left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), moderate or greater mitral stenosis, or severe right-sided valvular disease based on baseline echo at the time of enrollment 15. Current angina due to clinically significant epicardial coronary disease, as per investigator judgment 16. Acute coronary syndrome or coronary intervention within the past 2 months 17. Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension) 18. Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease meeting Stage III or greater GOLD criteria (FEV1\<50% predicted), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, or current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea. 19. Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test) 20. Symptomatic bradycardia or second- or third-degree heart block, in the absence of a pacemaker 21. Significant liver disease impacting synthetic function or volume control (ALT/AST \> 3x ULN, Albumin \< 3.0 g/dL) 22. Severe right ventricular dysfunction on baseline echocardiogram 23. Orthostatic blood pressure response to the transition from supine to standing (\>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing) 24. Active participation in another study that utilizes an investigational agent (observational studies/registries allowed) 25. Any condition that, in the opinion of the investigator, will interfere with the completion of the study. This may include comorbid or psychiatric conditions that may impede successful completion of the protocol, or logistical concerns (e.g. inability to travel to the exercise unit). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sharlene Day, MD **Phone:** 734-548-0394 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kim Clinton **Phone:** 215-431-4545 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Pennsylvania **Name:** Sharlene Day, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** No individual participant data will be available to other researchers **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000001020 - Term: Aortic Stenosis, Subvalvular - ID: D000001024 - Term: Aortic Valve Stenosis - ID: D000082862 - Term: Aortic Valve Disease - ID: D000006349 - Term: Heart Valve Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophic - ID: M12154 - Name: Cardiomyopathies - Relevance: HIGH - As Found: Cardiomyopathy - ID: M5568 - Name: Cardiomyopathy, Hypertrophic - Relevance: HIGH - As Found: Hypertrophic Cardiomyopathy - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M4340 - Name: Aortic Valve Stenosis - Relevance: LOW - As Found: Unknown - ID: M2379 - Name: Aortic Valve Disease - Relevance: LOW - As Found: Unknown - ID: M9437 - Name: Heart Valve Diseases - Relevance: LOW - As Found: Unknown - ID: T449 - Name: Aortic Valve Stenosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009202 - Term: Cardiomyopathies - ID: D000002312 - Term: Cardiomyopathy, Hypertrophic - ID: D000006984 - Term: Hypertrophy ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M254783 - Name: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol - Relevance: HIGH - As Found: Approximate - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000575681 - Term: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433037 **Acronym:** PRECODE **Brief Title:** Gut-brain Health Effects of PREbiotics in Older Adults With Suspected COgnitive DEcline **Official Title:** Gut-brain Health Effects of PREbiotics in Older Adults With Suspected COgnitive DEcline: The PRECODE Study #### Organization Study ID Info **ID:** NL85910.091.23 #### Organization **Class:** OTHER **Full Name:** Wageningen University ### Status Module #### Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Sensus BV **Class:** UNKNOWN **Name:** Cosun Nutrition Center **Class:** UNKNOWN **Name:** Roquette Frères **Class:** UNKNOWN **Name:** Oceanium Ltd. **Class:** UNKNOWN **Name:** Technical University of Eindhoven (TU/e) #### Lead Sponsor **Class:** OTHER **Name:** Wageningen University #### Responsible Party **Investigator Affiliation:** Wageningen University **Investigator Full Name:** Yannick Vermeiren **Investigator Title:** Assistant Professor in Nutrition, Brain and Cognitive Aging **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** As people around the world are living longer, the number of individuals with dementia, particularly Alzheimer's disease (AD), is expected to triple by 2050. There's growing evidence suggesting that our gut health might play a role in the prevention of dementia. The connection between our gut and brain, known as the gut-brain axis, is becoming an important area of study. Research in animals has shown that different types of dietary fibre can improve gut health, brain function, mood, blood sugar level and the immune system and may even prevent certain harmful brain changes seen in Alzheimer's disease. Subjective Cognitive Decline (SCD) is a condition where individuals notice a decline in their mental abilities, and it can be an early sign of Alzheimer's disease. The goal of this clinical trial is to learn if dietary fibres can improve gut and brain health in older individuals, between the ages of 60 and 79 years, who notice problems in their mental abilities, and meet the criteria of SCD. Three different dietary fibres will be given, and researchers will compare three different fibres to a placebo product to see if there is a difference between the fibres and the placebo. The main questions it aims to answer are: 1. Does dietary fibre improve working memory? 2. Does dietary fibre improve other markers of brain function? 3. Does dietary fibre improve gut health? 4. Does dietary fibre improve the immune system and blood glucose levels? 5. Does dietary fibre improve mood? Participants will: * Consume dietary fibres twice a day, mixed in water, tea or coffee, for a period of 26 weeks * Have two functional MRI scans, and three additional study visits, where blood, urine and feces will be collected * Undergo a number of neuropsychological tests, aimed at evaluating brain function * Fill out questionnaires on their general health, mood, dietary habits, gut health * Wear smartwatches for one week, at the beginning and the end of the study **Detailed Description:** Rationale: Due to the greying of society, a triplication of the number of people with dementia worldwide, with Alzheimer's disease (AD) as the commonest form, is expected by 2050. Compelling evidence points towards a crucial role of intestinal health as one potential etiological modifier of dementia, with the (microbiota) gut-brain axis (MGBA) receiving increasing attention. A number of preclinical studies have demonstrated benefit of various sources of dietary fibre for their capacity to improve gut health, cognitive functioning, general mood, glycaemia, immunogenicity, and, to inhibit tau phosphorylation, the latter which is a hallmark in AD brain. Subjective cognitive decline (SCD) lies on the continuum of AD, and subjects with this condition are at increased risk of further conversion to mild cognitive impairment (MCI) or AD. Currently, no cure is available for AD. Various symptomatic and a few disease-modifying treatments are available, but these treatments only have very limited or mild clinical effects and are often accompanied by severe side effects. Clinical follow-up studies to evaluate the effect of dietary fibre in older adults with suspected cognitive decline are required, but are still lacking to date. Objective: The primary objective of this study is to investigate the effect of 26 weeks of supplementation with three different dietary fibres (chicory inulin, resistant dextrin, and seaweed polysaccharide) compared to a placebo (maltodextrin) on microbiota gut-brain health effects in older adults (aged 60-79) with Subjective Cognitive Decline Plus (SCD+) by assessing changes in brain function and working memory by blood oxygen level dependant (BOLD) signal activity and task accuracy during n-back task functional magnetic resonance imaging (fMRI) assessment. The secondary objectives are to investigate the effects of 26 weeks of supplementation with dietary fibre (chicory inulin, resistant dextrin, and, seaweed polysaccharide) compared to placebo (maltodextrin) in older adults on the following parameters related to potential gut-brain pathways: 1. neuropsychological test battery scoring, 2. other relevant brain health parameters, 3. relevant intestinal health parameters, and 4. immune and metabolic parameters. Study population: 164 older adults (60-79 years) with SCD+. Study design implementation: Participants will undergo assessments at baseline (T0), mid-study (T1/2, after 13 weeks) and at study end (T1, after 26 weeks. Each participant will have five study visits in total: two at T0, one at T1/2 and two at T1. At each of the timepoints the following will be collected/performed at WUR: Sample collection (blood, urine (omitted in week 13), faeces); general cognitive assessments (see NTB; Cognitive Failure Questionnaire (CFQ) (baseline and end only), GDS-15, GAD-7); general physiological measures (blood pressure, BMI, grip-strength); dietary assessment (MIND-adjusted Eetscore, FFQ). At ZGV working memory will be evaluated using BOLD fMRI signalling and task accuracy using an n-back task paradigm. Additionally, high-resolution T1- and T2-weighted anatomical images of main regions of interest (hippocampi, (pre)frontal-, and temporal cortices) will be acquired. For two periods of one week, corresponding with the baseline and week 26 visits, participants will wear smartwatches. These watches will be worn continuously and data will be gathered regarding cardiovascular functioning (heart rate), physical activity and mood (push messages). ### Conditions Module **Conditions:** - Subjective Cognitive Decline **Keywords:** - gut-brain axis - working memory - gut health - dietary fibres - prebiotics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomised, double-blinded, placebo-controlled intervention study with parallel design and four arms. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 164 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Dietary Supplement: Placebo **Label:** Maltodextrin **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Intervention Names:** - Dietary Supplement: Chicory inulin **Label:** Chicory inulin **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Dietary Supplement: Resistant dextrin **Label:** Resistant dextrin **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Dietary Supplement: Seaweed polysaccharide **Label:** Seaweed polysaccharide **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Chicory inulin **Description:** Chicory inulin (12g/day) divided over two dosages (6g per dose) **Name:** Chicory inulin **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Resistant dextrin **Description:** Resistant dextrin (14g/day) divided over two dosages (7g per dose) **Name:** Resistant dextrin **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - Seaweed polysaccharide **Description:** Seaweed polysaccharide (1g/day) divided over two dosages (0.5g per dose). Additionally contains 7g/day of placebo as a volumetric and isocaloric filler. **Name:** Seaweed polysaccharide **Type:** DIETARY_SUPPLEMENT #### Intervention 4 **Arm Group Labels:** - Maltodextrin **Description:** Maltodextrin (7g/day) will be provided in two divided doses (3.5g per dose) **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** Heart rate as determined by wearable Samsung Active 2.0 Smartwatches **Measure:** Effect on heart rate **Time Frame:** Measured at baseline and week 26 **Description:** Physical activity (pedometer) as determined by wearable Samsung Active 2.0 Smartwatches **Measure:** Effect on physical activity **Time Frame:** Measured at baseline and week 26 **Description:** Measured in kg/m\^2 **Measure:** Effect on BMI **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Systolic and diastolic blood pressure as measured by sphygmomanometer **Measure:** Effect on blood pressure **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Mood determined by push notifications (sad, stressed, neutral, happy, or angry) as determined by wearable Samsung Active 2.0 Smartwatches **Measure:** Effect on mood as measured by Samsung Active 2.0 Smartwatches **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Self-reported depressive symptoms by Geriatric Depression Scale-15 (GDS-15) questionnaire **Measure:** Effect on mood as determined by GDS-15 questionnaire **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Self-reported anxiety symptoms by Generalised Anxiety Disorder-7 (GAD-7) questionnaire **Measure:** Effect on mood as determined by GAD-7 questionnaire **Time Frame:** Measured at baseline, week 13 and week 26 #### Primary Outcomes **Description:** Effects on working memory will be assessed by blood-oxygen level dependant (BOLD) signal activity during 2-back task performed during fMRI scanning **Measure:** Effect on working memory during n-back task fMRI **Time Frame:** Measured at baseline and week 26 **Description:** Effects on working memory performance will be assessed by task accuracy during 2-back task performed during fMRI scanning **Measure:** Effect on working memory performance during n-back task fMRI **Time Frame:** Measured at baseline and week 26 #### Secondary Outcomes **Description:** Effect on z-scoring of cognitive domains- episodic memory, executive function and working memory as measured by Cognitive Function Composite test battery **Measure:** Effect on cognitive functioning as measured by a neuropsychological test battery **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Mean number of correct responses across three trials; Score 0 to 10. Higher score indicates better outcome. **Measure:** Effect on ADAS-Cog Word Recall cognitive assessment (episodic memory) **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Mean number of correct responses across three trials. Score 0 to 12. Higher score indicates better outcome. **Measure:** Effect on ADAS-Cog Word Recognition cognitive assessment (episodic memory) **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Amount of symbols correctly substituted. Score 0 - 90. Higher score indicates better outcome **Measure:** Effect on Digit Symbol Substitution Test cognitive assessment (executive function) **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Longest span of digits correctly recalled. Score 2-8. Higher score indicates better outcome **Measure:** Effect on Digit Span Backward Task cognitive assessment (working memory) **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Number of uniquely named items from category within 60 seconds. Higher score indicates better outcome **Measure:** Effect on Category Fluency Test cognitive assessment (executive function) **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** The number of correct responses on orientation. Score 0 to 8. Higher score indicates better outcome **Measure:** Effect on ADAS-Cog Orientation cognitive assessment (episodic memory) **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Tryptophan related neurotransmitters and metabolites (plasma) **Measure:** Effect on tryptophan metabolites **Time Frame:** Measured at baseline and week 26 **Description:** Aβ1-42/Aβ1-40 ratio (plasma) **Measure:** Effect on amyloid-beta (Aβ) biomarker **Time Frame:** Measured at baseline and week 26 **Description:** Brain-derived neurotrophic factor (BDNF) levels (serum) **Measure:** Effect on neuroplasticity **Time Frame:** Measured at baseline and week 26 **Description:** Structural MRI with T1- and T2-weighted anatomical images of regions of interest (hippocampi, (pre)frontal-and temporal cortices) **Measure:** Effect on brain regions of interest **Time Frame:** Measured at baseline and week 26 **Description:** Cortisol levels (serum) **Measure:** Effect on hypothalamic-pituitary adrenal axis **Time Frame:** Measured at baseline and week 26 **Description:** Assay-based panel of intestinal barrier integrity markers measured in blood **Measure:** Effect on intestinal barrier integrity **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Assay-based panel of intestinal inflammatory markers measured in faeces **Measure:** Effect on intestinal inflammation **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Gut transit time measured by blue muffin consumption and appearance of blue colour in faeces **Measure:** Effect on gastrointestinal transit time **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Self-rated gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire **Measure:** Effect on gastrointestinal symptoms **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Effect on stool consistency as measured by Bristol Stool Scale (BSS) **Measure:** Effect on self-reported stool consistency **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Effect on stool consistency as measured by faecal water content **Measure:** Effect on stool consistency **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Qualitative faecal microbiota composition as measured by 16s rRNA sequencing **Measure:** Effect on qualitative faecal microbiota composition **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Quantitative faecal microbiota composition as measured by digital droplet PCR **Measure:** Effect on quantitative faecal microbiota composition **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Faecal short-chain fatty acids (acetic acid, propionic acid, butyric acid, valeric acid, hexanoic acid, heptanoic acid) and branched-chain fatty acids (isobutyric acid, isovaleric acid, 4-methyl valeric acid) as measured by gas chromatography-flame ionization detection (GC-FID) **Measure:** Effect on faecal metabolites **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Faecal pH measurement **Measure:** Effect on faecal pH **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Inflammatory cytokine panel measured in blood **Measure:** Effect on immune parameters **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Assay-based panel of markers to evaluate glucose homestasis in blood **Measure:** Effect on glucose homeostasis **Time Frame:** Measured at baseline, week 13 and week 26 **Description:** Assay-based panel of markers to analyse lipid profile in blood **Measure:** Effect on lipid profile **Time Frame:** Measured at baseline, week 13 and week 26 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Written informed consent 2. Fluency in Dutch (speaking, reading, writing) 3. Age between 60-79 years (at screening) 4. Subjective cognitive decline plus (SCD+), (criteria of Jessen et al.): 4.1 Self-reported worsening of memory; 4.2 Indication of repetitive concerns (worries) associated with SCD; 4.3 With at least one of the following two features present: (i) onset of SCD within the last 5 years; (ii) age at onset ≥60 years of age; 5. Presence of at least 2 self-reported risk factors for cognitive decline (based on LIBRA criteria): (i) Diabetes mellitus type II (ii) High cholesterol (iii) Hypertension (iv) High BMI (v) Heart disease (vi) Unhealthy diet (lower regular adherence to Mediterranean diet components such as fish, vegetables, olive oil, pasta and red wine) Exclusion Criteria: 1. Current participation in other intervention trials 2. Technologically illiterate (complete incompetence in working with computers, apps, online questionnaires, smartwatches etc.) 3. No internet access from home 4. Clinical diagnosis of ≥1 of the following: * Neurological pathology (e.g. MCI, dementia, multiple sclerosis, Parkinson's disease, epilepsy); * Current malignant disease(s), with or without treatment; * Current psychiatric disorder(s) (e.g. major depressive disorder, bipolar disorder, schizophrenia, anxiety, psychosis, PTSD); * Symptomatic/decompensated cardiovascular disease (e.g. stroke, angina pectoris, heart failure, recent myocardial infarction); * Severe visual impairment or blindness * Hearing or communicative impairment. * Gastrointestinal tract disorder such as irritable bowel syndrome or inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis). 5. Current or recent (\<6 weeks) use of prebiotic, probiotic, or dietary fibre supplement that may modulate the microbiota, or unwilling to stop the use of supplements during the study 6. Current or recent (\<6 weeks) of algae/phytoplankton supplements such as spirulina or chlorella, or unwilling to stop the use of supplements during the study 7. Use of psychotropic medication (anti-depressants, anti-psychotics) 8. Use of antibiotics in the 3 months before starting the study or planned use during the study 9. Being an employee of the Human Nutrition and Health Division of Wageningen University. 10. Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICS-m score \<23) 11. Request to have Apo-E genotype result disclosed 12. Allergies to fish or shellfish 13. Having a contra-indication to MRI scanning including: * Ferromagnetic implants: * Active implantable medical devices such as: insulin pump / medicine pump / neurostimulator; pacemaker / defibrillator; * Other passive implants such as: punctured port-a-cath; synthetic heart valve * Intra-orbital or intra-ocular metallic fragments * Claustrophobia **Maximum Age:** 79 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yannick Vermeiren, PhD **Phone:** +31618520620 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kirsten Kruger, MD **Phone:** +31633713080 **Role:** CONTACT #### Locations **Location 1:** **City:** Wageningen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yannick Vermeiren, PhD - **Role:** CONTACT **Country:** Netherlands **Facility:** Wageningen University ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** PRECODE study Wageningen University **URL:** http://www.wur.nl/en/research-results/research-institutes/food-biobased-research/show-fbr/gut-brain-health-effects-of-prebiotics-in-older-adults-with-suspected-cognitive-decline-the-precode-study.htm ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Cognitive Decline - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000060825 - Term: Cognitive Dysfunction ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: T401 - Name: Inulin - Relevance: HIGH - As Found: GnRH - ID: T105 - Name: Chicory - Relevance: HIGH - As Found: All teeth ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433024 **Brief Title:** Training of a Artificial Intelligence Model to Detect Venous Diseases Using PPG Technology **Official Title:** A Pilot Study Using AI Algorithms and PPG Technology for the Detection of Venous Diseases #### Organization Study ID Info **ID:** TWC-SD-2024-05 #### Organization **Class:** OTHER **Full Name:** The Whiteley Clinic ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Whiteley Clinic #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This clinical research aims to evaluate the effectiveness of using Photoplethysmography (PPG) signals combined with Artificial Intelligence (AI) algorithms, for the precise classification and diagnosis of Venous Diseases of the lower limb. This study invites a group of participants who currently undergoing investigations for venous disease at The Whiteley Clinic (hereinafter referred to as TWC). The Participants will be classified into control (healthy individuals with no significant venous disease) and chronic venous disease (CVD) (diagnosed with proven venous disease) groups. Prospective participants who express an interest in being included in the study will be given a patient information sheet and will undergo a briefing of the pilot study. If they consent and sign the relevant consent forms, the participants will perform a series of standardized exercises under the supervision of a consultant vascular surgeon. Throughout the exercises, a data acquisition device attached to the ankle records the PPG signals, capturing the changes in blood volume due to the reflected PPG signals from the red blood cells during the movement. Thus, once the data is collected and recorded, this allows for the analysis of the data of the control group and CVD group against each other. During the analysis of the two groups' PPG signals, the objective lies within the capability to detect subtle nuances in the patterns of the PPG signals during the performed movements using AI algorithms. The AI algorithms will distinguish patterns or features indicating the presence or absence of venous disease. This study seeks to contribute valuable insights into enhancing the diagnosis of venous disease using PPG and AI algorithms, paving novel approaches to Venous healthcare. ### Conditions Module **Conditions:** - Venous Disease ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who have been diagnosed with Chronic Venous Disease (CVD). **Intervention Names:** - Diagnostic Test: PPG Diagnostic **Label:** Individuals with CVD (Treatment Group) #### Arm Group 2 **Description:** Participants who have not been diagnosed with CVD. **Intervention Names:** - Diagnostic Test: PPG Diagnostic **Label:** Individuals Without CVD (Control Group) ### Interventions #### Intervention 1 **Arm Group Labels:** - Individuals Without CVD (Control Group) - Individuals with CVD (Treatment Group) **Description:** The study investigates venous competence through three distinct exercises using photoplethysmography (PPG) technology to record blood flow in the leg veins of 20 subjects, split into two groups: those with chronic venous disease (CVD) and those without. The null hypothesis is that there will be no significant difference in venous filling times (VFT) and PPG trace variations between subjects with CVD and those without under different physical conditions. The alternative hypothesis suggests that individuals with CVD will show distinct PPG patterns, particularly shorter VFT and varied pressure changes, indicative of venous reflux or obstruction. This hypothesis is chosen based on prior evidence suggesting observable differences in venous function between affected and non-affected individuals. **Name:** PPG Diagnostic **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome measure of this study is to evaluate the diagnostic accuracy of an AI model in detecting venous disease through the using PPG signals. This will be quantified by assessing the sensitivity and specificity of the AI model when analysing PPG signals from healthy participants without venous diease, and non-healthy participants with venous disease, without the need for direct intervention of a vascular consultant. These results will help evaluate the AI model in terms of how accurately it can identify Venous disease. **Measure:** Diagnostic Accuracy of an AI Model for Venous Disease Detection Using PPG Signals **Time Frame:** June 2024 - September 2024 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients are attending for investigation of suspected venous disease. Patients must be able to walk and mobile normally and have good skin integrity of the lower leg, where the PPG is attached. All patients attending TWC are 18 years or older. Exclusion Criteria: * Subjects with known arterial occlusive disease or physical disability affecting gait or ankle movement will be excluded. Patients unable to have a PPG attached to the lower leg (ie: active ulceration) will be excluded. Patients unable to give consent. Pregnant female. **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This study invites a group of participants who have attended The Whiteley Clinic (hereinafter referred to as TWC). The Participants are split into control (healthy individuals) and treatment (previously diagnosed with Venous disease) groups. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sergio Da Silva, PhD **Phone:** 01483477199 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Serah Duro, MSc **Role:** CONTACT #### Locations **Location 1:** **City:** Guildford **Country:** United Kingdom **Facility:** The Whiteley Clinic **Zip:** GU2 7RF #### Overall Officials **Official 1:** **Affiliation:** The Whiteley Clinic **Name:** Mark Whiteley **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06433011 **Brief Title:** The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism **Official Title:** The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism #### Organization Study ID Info **ID:** THRO-CLIN-2024-01 #### Organization **Class:** INDUSTRY **Full Name:** Thrombolex, Inc. ### Status Module #### Completion Date **Date:** 2027-08-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Thrombolex, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE). **Detailed Description:** The BASHIR™ .035 Endovascular Catheter (BEC) and the BEC Short Basket .035 (S-B) are devices intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The distal infusion segment of the device contains an expandable radial array of conduits with a total of 48 laser drilled orifices used for the delivery of the therapeutic agents at multiple cross-sectional points of the target vessel location. The infusion segment can be expanded and collapsed by the actuator (slider) located on the handle at the proximal end of the device. The infusion line connector is also located on the handle. The difference between the BEC .035 and the BEC S-B.035 is solely in the length of the basket. In its unexpanded state, the basket of the BEC .035 is 12.5cm long and the BEC S-B .035 basket is 10cm long. The choice of device used will be at the physician's discretion based on the patient's anatomy. ### Conditions Module **Conditions:** - Pulmonary Embolism **Keywords:** - Pulmonary Embolism - Catheter Directed Therapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single Group Assignment Pulse Spray and Infusion of r-tPA ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. **Intervention Names:** - Device: The Bashir™ Endovascular Catheter - Drug: r-tPA **Label:** BEC Treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - BEC Treatment **Description:** The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. **Name:** The Bashir™ Endovascular Catheter **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - BEC Treatment **Description:** Pulse spray and infusion **Name:** r-tPA **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Observe death from any cause or hemodynamic decompensation (or collapse) through 7-day follow-up, defined as need for cardiopulmonary resuscitation; or 1. SBP \< 90 mmHg for at least 15 minutes; or 2. drop in SBP by at least 40 mmHg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output \< 30 mL/h or mental confusion); or 3. need for catecholamine administration to maintain adequate organ perfusion and a SBP \> 90 mmHg (including dopamine at the rate of \> 5 micrograms / kg per minute). **Measure:** Efficacy: Death from any cause or hemodynamic decompensation (or collapse) **Time Frame:** Procedure through 7-day follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria 1. Willing and able to provide informed consent; 2. PE symptom duration ≤ 15 days; 3. Filling defect in at least one major lobar pulmonary artery as determined by CTA; 4. Patient is diagnosed with intermediate risk PE; 5. RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site; 6. Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit. Exclusion Criteria: 1. Previous history of stroke with residual hemiplegia; 2. Major surgery ≤ 10 days prior to inclusion in the study; 3. Platelet count \< 100,000/μL; 4. Pulmonary thrombectomy within the previous 4 days; 5. Uncontrolled hypertension defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at the time of the procedure; 6. Administration of thrombolytic agents within the previous 4 days; 7. Absolute contraindication to anticoagulation; 8. Clinician deems high-risk for catastrophic bleeding; 9. Pregnancy; 10. Any vasopressor or inotropic support; 11. Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution; 12. Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays; 13. Currently participating in another study; 14. In the opinion of the investigator, the subject is not a suitable candidate for the study. **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chris Schultz, BS **Phone:** 971-506-7552 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lynn Begovac, MS **Phone:** 928-600-3599 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Thrombolex, Inc. **Name:** Jeff Mifek **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14509 - Name: Pulmonary Embolism - Relevance: HIGH - As Found: Pulmonary Embolism - ID: M7784 - Name: Embolism - Relevance: HIGH - As Found: Embolism - ID: M16686 - Name: Thrombosis - Relevance: LOW - As Found: Unknown - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011655 - Term: Pulmonary Embolism - ID: D000004617 - Term: Embolism ### Intervention Browse Module - Browse Branches - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13849 - Name: Tissue Plasminogen Activator - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432998 **Brief Title:** Perineal Massage in Women With Gynecological Cancer **Official Title:** Oncological Perineal Massage in Vaginal Stenosis and Dyspareunia in Women With Gynecological Cancer #### Organization Study ID Info **ID:** CHUNSC_2023_104 #### Organization **Class:** OTHER **Full Name:** University of Alcala ### Status Module #### Completion Date **Date:** 2024-12-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Alcala #### Responsible Party **Investigator Affiliation:** University of Alcala **Investigator Full Name:** Prof. Dr. Daniel Pecos Martín **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The high incidence of gynecological cancers, together with dyspareunia and vaginal stenosis, some of its most frequent sequelae, create the need to continue studying and researching oncological physiotherapy techniques that treat and prevent these sequelae, in order to preserve and/or improve the quality of life of cancer patients. Therefore, through this study, we sought to verify the effectiveness of oncological perineal massage to treat pain during sexual intercourse and vaginal stenosis. The objective of this study will be to demonstrate the effectiveness of a treatment that will consist of a health education session related to the pelvic floor and the consequences related to cancer along with ten sessions of oncological perineal massage that will be carried out for fifty minutes, once a week. ### Conditions Module **Conditions:** - Cancer Pain - Neck Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 86 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ten sessions of perineal massage, which will be carried out for fifty minutes, once a week, together with a health education program. **Intervention Names:** - Other: Perineal massage **Label:** Perineal massage **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A health education session will be held but then the use of vaginal dilators will be done according to the gold standard treatment. **Intervention Names:** - Other: Standard treatment **Label:** Treatment with dilators **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Perineal massage **Description:** The technique will be applied for approximately twenty minutes and will be carried out as follows: the vaginal dilator is introduced progressively using crescent-shaped movements. Once the dilator is fully inserted, movements will be made from bottom to top and from one side to the other, and then continue with the crescent-shaped movements. **Name:** Perineal massage **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Treatment with dilators **Description:** The treatment will consist of the use of vaginal dilators according to the gold standard proposed in the literature. It will consist of introducing the same dilators as for the experimental group, with the same time schedule, but without massage, only introducing the dilator and keeping it in the vagina for 20 minutes. **Name:** Standard treatment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Visual Analogical Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left "0" (worst) to the right "10"(best) **Measure:** Pain (Visual Analoge Scale) **Time Frame:** Change from baseline at six months #### Secondary Outcomes **Description:** Grade refers to the severity of the Adverse Events. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on a general guideline where grade 1 and grade 5 are the best and worst result respectively. **Measure:** Criteria for Adverse Events (CTCAE) **Time Frame:** Change from baseline at six months **Description:** The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The scores obtained can have values between 0 and 100, which determines the level of impact of the cancer on the patient of each of the scales. High values on the global health and function status scales indicate a better quality of life, while on the symptoms scale it would indicate a decrease in quality of life since it indicates the presence of symptoms associated with cancer. **Measure:** Quality of life (EORCT QLQ-C30) **Time Frame:** Change from baseline at six months **Description:** Female sexual function index (FSFI) is a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain.The items are then scaled to achieve a maximum score of 36. **Measure:** Female sexual function index **Time Frame:** Change from baseline at six months **Description:** Likert scales are a structured way for researchers to gather diverse opinions and attitudes. They allow respondents to express agreement, disagreement, or neutrality concerning statements or questions. The scale values range from 1 to 5, with 1 being the worst result and 5 being the best result. **Measure:** Likert questionnaire by sexual dysfunction **Time Frame:** Change from baseline at six months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women between 18 and 52 years old * Oncology patients with a diagnosis of dyspareunia and vaginal stenosis related to treatments. * Patients with QT/RT/BT treatment who have a diagnosis of dyspareunia and vaginal stenosis. * Patients on hormonal suppressive treatment with a diagnosis of dyspareunia and vaginal stenosis. Exclusion Criteria: * Patients who do not accept intracavitary treatment. * Patients with abdominopelvic surgical treatment prior to oncological process. * Patients with a diagnosis of dyspareunia prior to cancer. * Patients with vaginal narrowing prior to cancer. * Patients with menopause at the time of cancer diagnosis **Gender Based:** True **Gender Description:** Women diagnosed with vaginal stenosis and dyspareunia due to cancer **Maximum Age:** 52 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Raquel Perez-Garcia **Phone:** +34 922276912 **Role:** CONTACT #### Locations **Location 1:** **City:** Santa cruz de Tenerife. **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Raquel Perez-Garcia - **Phone:** +34 922276912 - **Role:** CONTACT **Country:** Spain **Facility:** Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife. **State:** Tenerife #### Overall Officials **Official 1:** **Affiliation:** Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife. **Name:** Raquel Perez-García **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M1091 - Name: Cancer Pain - Relevance: HIGH - As Found: Cancer Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M7588 - Name: Dyspareunia - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000072716 - Term: Cancer Pain ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432985 **Acronym:** CM_TUD_Cancer **Brief Title:** Smoking Cessation CM for Veterans With or at Risk for Cancer **Official Title:** Contingency Management for Veteran Smokers With or at Risk for Cancer #### Organization Study ID Info **ID:** NURA-006-23F #### Organization **Class:** FED **Full Name:** VA Office of Research and Development #### Secondary ID Infos **Domain:** University Of California, San Francisco **ID:** 24-40951 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2030-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2030-03-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of California, San Francisco #### Lead Sponsor **Class:** FED **Name:** VA Office of Research and Development #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being. The aim of this project is to evaluate the effectiveness of a program called Contingency Management (CM) in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics. CM is a behavioral treatment that uses rewards to encourage smoking cessation when verified through biological testing. In the first year, the researchers will develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups. In the second year, they will conduct a pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans over a five-week period. The success of the pilot study will determine whether to proceed with a larger randomized controlled trial (RCT) in years three to six, comparing the efficacy of mobile CM with standard treatment. The project will take place at SFVA. **Detailed Description:** Smoking at the time of lung cancer screening (LCS) or cancer diagnosis is associated with treatment failure, shortened lifespan, and diminished quality of life. Beyond the increased morbidity and mortality, smoking after a cancer diagnosis is associated with an estimated $3.4 billion in healthcare costs. Despite these risks, the VA does not routinely integrate smoking cessation treatment into LCS screening or cancer care, and quit rates are low. Contingency Management (C) is a behavioral therapy approach that reinforces desired behaviors, such as smoking cessation, through the provision of tangible rewards or incentives. The goal of this Proof of Concept and Clinical Trial project is to evaluate the acceptability, feasibility, and efficacy of Contingency Management (CM) for smoking cessation among Veterans in lung cancer screening (LCS) or cancer care in Veterans Affairs (VA) clinics. Research indicates that CM must be tailored to the clinical population and context. This staged investigation will occur in three phases. First, the investigators will conduct Focus Groups, to iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff. Afterward, the investigators will conduct a Pilot Study to examine the feasibility of mobile smoking cessation CM with for VA patients in LCS or in cancer care. In a single arm study, Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks. If successful, the investigators will conduct a Randomized Controlled Trial (RCT) to assess efficacy of mobile CM compared with treatment as usual (TAU). Veterans diagnosed with cancer or in LCS will be randomized to receive a 5-week CM condition (CM plus behavioral counseling) or TAU (referral to VA Tobacco Cessation Clinic and VA quitline). Both groups will receive pharmacotherapy. The primary aims of this study are to develop an acceptable mobile CM protocol through qualitative feedback from Veterans and VA staff, to examine the feasibility of mobile smoking cessation CM among Veterans in LCS or cancer care through a pilot study, and to assess the efficacy of mobile CM compared to treatment as usual through a randomized controlled trial among Veterans diagnosed with cancer or in LCS. ### Conditions Module **Conditions:** - Tobacco Use Disorder - Substance Use Disorder **Keywords:** - Tobacco - Contingency Management - Lung Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel Assignment ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double-blind Masking **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 95 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The investigators will iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff. **Intervention Names:** - Behavioral: Focus Group **Label:** Focus Group **Type:** OTHER #### Arm Group 2 **Description:** Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks. **Intervention Names:** - Behavioral: Contingency Management - Behavioral: Behavioral Counseling (Cognitive Behavioral Therapy, CBT) **Label:** Contingency Management **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants assigned to TAU will receive time-matched Medication Management plus usual care (referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline). **Intervention Names:** - Behavioral: Behavioral Counseling (Cognitive Behavioral Therapy, CBT) - Behavioral: TUD Treatment as Usual (TAU) **Label:** TUD Treatment as Usual **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Focus Group **Description:** In 60-minute focus groups, participants will be categorized based on their survey responses and engaged in semi-structured discussions using open-ended questions and probes to gather detailed information. The moderators will follow best practices in qualitative research, introducing the topic of smoking cessation in the context of cancer screening and treatment and guiding the discussions from broader issues to participant-generated examples. **Name:** Focus Group **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Contingency Management **Description:** Participants will provide baseline data on their recent substance use and smoking habits and severity. They will receive a CO monitor and iCO app and will upload videos verifying smoking abstinence a minimum of once per day, 5 times per week. Financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through Remote (mobile) CO monitoring. They will receive clinician feedback at the time of each CO reading, following established VA protocols for CM. **Name:** Contingency Management **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Contingency Management - TUD Treatment as Usual **Description:** Participants will receive a 5-session smoking cessation behavioral counseling for approximately 15-20 minutes weekly. Sessions may be held by secure video conference or by telephone, per participant preference. Sessions will use CBT principles with MI incorporated for resolving reluctance to quit. **Name:** Behavioral Counseling (Cognitive Behavioral Therapy, CBT) **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - TUD Treatment as Usual **Description:** Participants assigned to TAU will receive referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline. The VA Tobacco Cessation Clinic is modeled after VA Tobacco Cessation Clinics across all VA facilities and involves delivery of brief counseling and pharmacotherapy for TUD if desired. VA Telequit is a national toll-free number available to Veterans that allows them to speak with a smoking cessation counselor for a recommended minimum of five sessions to develop a quit plan and receive counseling, strategies to prevent relapse, and weekly proactive follow-up calls based on National Cancer Institute guidelines. **Name:** TUD Treatment as Usual (TAU) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Audio recordings will be analyzed by the research team using a template-based rapid analysis technique developed for health services research. A structured summary will be prepared, organized by topical areas drawn from the interview/focus group guide, to identify and describe themes within each topical domain. **Measure:** Focus Groups **Time Frame:** Baseline **Description:** Assesses age at first use, duration of use, use of all forms of nicotine and tobacco, prior quit attempts (defined as a period of intentionally not smoking for 24 hours), duration of cessation (if any), and presence of other tobacco users in the home. It will be used in the analytic process to correlate findings/themes with characteristics. **Measure:** Veteran Nicotine and Tobacco Use Questionnaire **Time Frame:** Phase 1, Baseline **Description:** It is a validated 46 item instrument that evaluates smoking-related knowledge, beliefs, self-efficacy, cessation treatment practices, and barriers to cessation treatment delivery among healthcare providers. The scores are from the summed items. Higher scores equal more tobacco treatment and the range of scores is 0-26. **Measure:** Smoking Knowledge, Attitudes and Practices Scale (S-KAP) **Time Frame:** Phase 1, Baseline **Description:** Assesses age, gender identity, sexual orientation, ethnicity, race, relationship status, income, education level, military history, service-connected disability status, housing status, and employment status. It will be analyzed through bivariate associations with outcomes (attendance, rate of video uploads). **Measure:** Participant Demographic Questionnaire **Time Frame:** Phase 2, week 0 **Description:** Study engagement will be assessed by tracking the number of participants attend each intervention session over the course of the 5-week intervention period. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models. **Measure:** Session Attendance **Time Frame:** Up to 5 Weeks **Description:** Study engagement will be assessed by the proportion of videos uploaded. Videos will be uploaded from Monday to Friday. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models. **Measure:** Remote (mobile) CO monitoring **Time Frame:** Phase 2, Weeks 2-5 **Description:** Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment. **Measure:** Recruitment yield number of participants enrolled **Time Frame:** Phase 2, Up to 5 Weeks **Description:** Study retention as assessed by the number of participants that completed the study. **Measure:** Study Retention **Time Frame:** Phase 2, 5 weeks **Description:** Assesses age, gender identity, sexual orientation, ethnicity, race, relationship status, income, education level, military history, service-connected disability status, housing status, and employment status. It will be analyzed through bivariate associations with outcome variables and primary independent variables. **Measure:** Participant Demographic Questionnaire **Time Frame:** Phase 3, week 0 **Description:** Self-reported use of medication for tobacco use disorder will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. **Measure:** Timeline Follow-Back (TLFB): TUD medication **Time Frame:** Phase 3, Weeks 0, 5, 12, 24 **Description:** The Contemplation Ladder is a visual analog comprised of 11 rungs and 5 anchor statements, representing stages of change. The response options (0) to (3) corresponded with the stage of precontemplation, (4) to (6) represented the stage of contemplation, (7) and (8) referred to the stage of preparation, (9) and (10) represented the stage of action and stage of maintenance respectively. It is a brief measure of motivation or readiness to change, where (0) is the least motivated and (10) is the most motivated. This measure has been validated for cigarette and other substance use. **Measure:** Change in Score on the Contemplation Ladder **Time Frame:** Phase 3, Weeks 0, 5, 12, 24 **Description:** Assesses age at first use, duration of use, use of all forms of nicotine and tobacco, prior quit attempts (defined as a period of intentionally not smoking for 24 hours), duration of cessation, and presence of other tobacco users in the home and will be completed in Week 0. At Follow Ups (Weeks 5, 12 and 24), the survey will inquire about frequency and duration of quit attempts **Measure:** Changes in Nicotine and Tobacco Use Survey **Time Frame:** Phase 3, Weeks 0, 5, 12, 24 **Description:** The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. **Measure:** Change in Scores on the Fagerström Test for Nicotine Dependence (FTND) **Time Frame:** Phase 3, Weeks 0, 5, 12, 24 **Description:** The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and scores are calculated by summing the item scores. The higher the total QSU score, the more intense are the participant's smoking urges. **Measure:** Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief) **Time Frame:** Phase 3, Weeks 0, 5, 12, 24 **Description:** Weekly self-reported use of cigarettes will be assessed with TLFB which uses a calendar with specific anchor dates to identify the quantity and frequency of use. **Measure:** Change in Timeline Followback (TLFB): Tobacco **Time Frame:** Phase 3, Weeks 2-5 **Description:** Self-reported use of tobacco will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. **Measure:** Change in Timeline Followback (TLFB): Tobacco **Time Frame:** Phase 3, Weeks 12, 24 **Description:** An iCO CO monitor will be used for the bio-verification of cigarette abstinence. Exhaled CO will be obtained using a study-issued iPad equipped with the iCO CO monitor and compatible app and the results will be shared through videos uploaded using VA-provided apps. Participants that report not smoking in the past 7 days and have CO levels \<6 parts per million (ppm) will be considered abstinent. For individuals with CO levels\> 6 ppm that report smoking cannabis who are not receiving NRT, salivary cotinine \<10 nanograms/ milliliter (ng/ml) will be used. **Measure:** Change in carbon monoxide (CO) levels **Time Frame:** Phase 3, Weeks 2-5 **Description:** Salivary Cotinine levels are an established method to biochemically verify a participant's smoking status. Participants will follow instructions provided to them in plain language describing procedures to test saliva for the presence or absence of cotinine to confirm abstinence. The cotinine test has several zones (0-6). Any result of with color in Zone 0 will be considered negative for tobacco use. **Measure:** Mean Salivary Cotinine Levels **Time Frame:** Phase 3, Weeks 5, 12, 24 #### Secondary Outcomes **Description:** Self-reported use of other substances will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity of use. **Measure:** Timeline Follow-Back (TLFB): Other substances **Time Frame:** Phase 2, Weeks 0, 5 **Description:** Self-reported use of medication for tobacco use disorder will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use. **Measure:** Change in Timeline Follow-Back (TLFB): TUD medication **Time Frame:** Phase 2, Weeks 0, 5 **Description:** Self-reported use of e-cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity of use. **Measure:** Change in Timeline Follow-Back (TLFB): E-cigarettes **Time Frame:** Phase 2, Weeks 0, 5 **Description:** Self-reported use of any other tobacco products will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity of use. **Measure:** Change in Timeline Follow-Back (TLFB): Other tobacco products **Time Frame:** Phase 2, Weeks 0, 5 **Description:** Seven-day point prevalence cigarette abstinence will be defined as the percentage of participants who have reported no smoking or nicotine use on the 7 consecutive days prior to the assessment with biochemically verified cotinine levels of \< 10 nanograms/ milliliter. **Measure:** Change in Percentage of Participants with Point Prevalent Abstinence **Time Frame:** Phase 3, Weeks 5, 12, 24 **Description:** Self-reported use of other substances will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use. **Measure:** Timeline Follow-Back (TLFB): Other substances **Time Frame:** Phase 2, Weeks 0, 5 **Description:** Self-reported use of medication for tobacco use disorder will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity use. **Measure:** Change in Timeline Follow-Back (TLFB): TUD medication **Time Frame:** Phase 2, Weeks 0, 5 **Description:** Self-reported use of e-cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use. **Measure:** Change in Timeline Follow-Back (TLFB): E-cigarettes **Time Frame:** Phase 2, Weeks 0, 5 **Description:** Self-reported use of any other tobacco products will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use. **Measure:** Change in Timeline Follow-Back (TLFB): Other tobacco products **Time Frame:** Phase 2, Weeks 0, 5 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Human Subjects Involvement and Characteristics: This Proof of Concept and Clinical Trial has three stages. The Proof-of-Concept Phase (Years 1-2) includes a Focus Group phase (Year 1) in which the investigators will recruit both Veterans and non-Veterans (VA clinical staff); and a Pilot Study (Year 2) in which the investigators will recruit Veterans in LCS or cancer treatment at San Francisco VA Healthcare System (SFVAHCS). If the Pilot Study is successful, the investigators will recruit Veterans in LCS or cancer treatment for the RCT (Years 3-6). * Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS. Veterans: * Age 18 years or older * Veteran eligible for VA healthcare * English-speaking * Received SFVAHCS cancer monitoring or treatment or LCS within the past 24 months * Active cigarette smoking within the past 24 months * Have access to Wi-Fi and a device that supports audio and video communication VA Clinical Staff: * Current member of clinical staff at the SFVAHCS * Have participated in the care of at least 5 VA cancer or LCS patients in the past 6 months Pilot Feasibility Study (Year 2) and Randomized Controlled Trial Inclusion criteria: * Age 18 years or older * Veteran currently receiving medical care at SFVAHCS (at least one clinical visit same calendar year for cancer) * English-speaking * Current, active (same calendar year) enrollment in VA LCS, or current (same calendar year) diagnosis of cancer documented in the VA medical record, confirmed through medical record review * Current (past 30 days) cigarette smoking a minimum of 1 cigarette per day (average), assessed by Timeline Followback (TLFB)92, 99-101 * Open to receiving smoking cessation interventions Exclusion Criteria: Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS. Veterans: Exclusion criteria: Assessed by Co-PIs' medical record review: * Current severe, untreated mental illness (i.e., psychosis, bipolar disorder, and/or substance use disorder (SUD)) and/or * Current (past 30 days) active suicidal/homicidal ideation or severe behavioral instability that would prevent participation * Never smokers or quit smoking for longer than 36 months prior to consent (4) no access to Wi-Fi or devices that support audio and video communication VA Clinical Staff: Exclusion Criteria: * Unable to commit 1.5 hours (60 min focus group and self-report questionnaires) Pilot Feasibility Study (Year 2) and Randomized Controlled Trial Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: * Evaluated by investigative team medical record review and clinical assessment: * Psychotic disorders, bipolar disorder, neurocognitive disorder, substance use disorders, or other psychiatric or medical conditions judged by the PI to be unstable in the past 30 days, based on M.I.N.I. Neuropsychiatric Inventory (M.I.N.I.) and/or medical record review, including conditions for which large sums of money would be potentially destabilizing * Untreated, current, active problem gambling, assessed by medical record diagnosis and/ or Problem Gambling Severity Index (PGSI) score 8 * Metastatic cancer or enrollment in end of life/ palliative care * Unable to commit to time commitment required for participation * Currently pregnant or planning to become pregnant during the study (people of childbearing potential ages 18-55 who are pregnant or state that they plan to become pregnant during the study) * A suicide attempt or suicidal ideation with intent in the 30 days prior to enrollment * Concurrent enrollment in a tobacco cessation clinical trial **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ellen Herbst, MD **Phone:** (415) 221-4810 **Phone Ext:** 24926 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Madeline Martinez Rivas, PhD **Phone:** (415) 221-4810 **Phone Ext:** 24926 **Role:** CONTACT #### Locations **Location 1:** **City:** San Francisco **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ellen Herbst, MD - **Phone:** 415-221-4810 - **Phone Ext:** 24926 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Madeline Martinez Rivas, PhD - **Phone:** (415) 221-4810 - **Phone Ext:** 24926 - **Role:** CONTACT ***Contact 3:*** - **Name:** Ellen Herbst, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** San Francisco VA Medical Center, San Francisco, CA **State:** California **Zip:** 94121-1563 #### Overall Officials **Official 1:** **Affiliation:** San Francisco VA Medical Center, San Francisco, CA **Name:** Ellen Herbst, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Provides Link to CM_TUD_Cancer Study **URL:** https://addictionresearch.ucsf.edu/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16785 - Name: Tobacco Use Disorder - Relevance: HIGH - As Found: Tobacco Use Disorder - ID: M21837 - Name: Substance-Related Disorders - Relevance: HIGH - As Found: Substance Use Disorders - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019966 - Term: Substance-Related Disorders - ID: D000014029 - Term: Tobacco Use Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432972 **Acronym:** PREHAB **Brief Title:** Accelerated Pulmonary Rehabilitation in the Preoperative Period **Official Title:** Accelerated Pulmonary Rehabilitation in the Preoperative Period #### Organization Study ID Info **ID:** STUDY00002705 #### Organization **Class:** OTHER **Full Name:** University of Vermont #### Secondary ID Infos **Domain:** American Lung Association **ID:** 1143233 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Vermont #### Responsible Party **Investigator Affiliation:** University of Vermont **Investigator Full Name:** Katherine Menson **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This proposed project will be a single arm, non-masked study. Participants who are actively smoking with a diagnosis of COPD and new lung nodule, either confirmed or suspicious for lung cancer, with a plan for surgical resection will be recruited from the University of Vermont Medical Center (UVMMC) Lung Multidisciplinary Clinic (LMDC). All patients will be enrolled in prehab and offered smoking cessation therapy. The acceptability and feasibility of this intervention will be measured by percent enrollment in study, attendance, barriers to completion, and monitoring of adverse events. The effect of prehab will be measured by traditional metrics, including fitness, respiratory symptoms, and depression scale. Research outcomes will be measured by smoking habits, anxiety, and surgical complications. Investigators estimate that 20 participants over a two-year period will be sufficient to measure the safety and feasibility of this study. Investigators aim to enroll, on average, 2 participants per month in order to complete this study in a timely fashion. Participants will be enrolled in prehab on a rolling basis, as to not delay surgical timeline. **Detailed Description:** The benefits of pulmonary rehab (PR) prior to lung resection have not been well-studied in the population that could benefit from it the most, patients with COPD who smoke. This study would be innovative in two major ways. First, the impact of prehab in those who smoke could be established. Secondly, the optimal model of prehab, which meets the clinical needs of the patient in the pre-surgical window, and aligns with the current model of PR, could be determined. Screening and Recruitment Investigators estimate that 20 participants over a two-year period will be sufficient to measure the safety and feasibility of this study. Investigators aim to enroll, on average, 2 participants per month in order to complete this study in a timely fashion. Participants will be enrolled in prehab on a rolling basis, as to not delay surgical timeline. Some procedures will be performed as a component of standard of care and some will be for research purposes only. This distinction is outlined in the sections below. Intake and Baseline Assessment After informed consent, participants will complete the initial assessment with study coordinator. This will include anthropometrics, demographics like age, sex, race and ethnicity, and other sociodemographic and economic characteristics such as education, marital status, income, etc. This assessment will also include thorough medical, surgical and COPD history review, healthcare resource utilization, medication usage, substance use and smoking history, specifically recall of average cigarettes per day, carbon monoxide measurements, Fagerström nicotine dependence scale, and readiness to change. Investigators will also administer the General Anxiety Disorder-7 (GAD-7) questionnaire to assess for anxiety. Following intake, participants will be enrolled in the prehab program, which will include standard of care intake measurements including 6-minute walk distance (6MWD), mMRC, SGRQ, short physical performance battery (SPPB), and PHQ-9. For ease of the patient, Investigators will offer that this be performed on the same day, in a private medical setting at the PR facility. If the patient chooses, Investigators can offer intake at the Vermont Lung Center on a separate day. Prehab Prehab will include 2, one-hour sequential sessions of PR per day as is standard, however this intervention will increase the frequency from 2 days to 4 days per week, for 2 weeks, thus completing 16 sessions of PR prior to surgery. An exercise prescription will be written by the medical director based on initial 6MWD, age, height, weight, and co-morbidities, as is standard of care. Prior to each session, patients are evaluated for symptoms and vital signs are measured. Exercise will include 30 minutes of warm-up and upper and lower extremity resistance training, either against gravity or with resistance bands as appropriate. Exercise will then move to the open gym, where patients utilize endurance equipment of their choosing, such as a treadmill or recumbent bicycle. As with traditional PR, participants will be given online education videos regarding lung health to complete at home, with a supplementary video on breathing techniques to reduce atelectasis from pain. Smoking Cessation Intervention Regarding smoking cessation, patients will be offered and prescribed the gold standard therapies in an attempt at smoking cessation, including a one-hour individual counseling session with a mental health therapist trained in smoking cessation therapy, varenicline treatment, dual acting NRT, and referral to the state smoking cessation program. Education modules on the benefits of smoking cessation will also be created for participants to review in the education portion of prehab. None of these interventions will be required, but offered as is standard of care. Assessments Post-Prehab and 30 Days Post- Lung Resection Surgery Following completion of prehab prior to lung resection surgery Pulmonary Rehabilitation standard of care assessments and research-based assessments will be repeated. This will include interim health history, healthcare resource utilization, and medication usage, assessment for adverse events and COPD exacerbations, substance use and smoking status including recall of average cigarettes per day, carbon monoxide measurements, Fagerström nicotine dependence scale, readiness to change, GAD-7 and the study evaluation. 30 days following lung resection surgery, the study team will review the participants medical record for any adverse events. ### Conditions Module **Conditions:** - Chronic Obstructive Pulmonary Disease - Lung Cancer Stage I - Lung Cancer Stage II - Lung Cancer Stage III **Keywords:** - Pulmonary Rehab ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Pulmonary Rehab **Label:** Prehab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Prehab **Description:** Prehab will include 2, one-hour sequential sessions of PR per day as is standard, however this intervention will increase the frequency from 2 days to 4 days per week, for 2 weeks, thus completing 16 sessions of PR prior to surgery. An exercise prescription will be written by the medical director based on initial 6MWD, age, height, weight, and co-morbidities, as is standard of care. Prior to each session, patients are evaluated for symptoms and vital signs are measured. Exercise will include 30 minutes of warm-up and upper and lower extremity resistance training, either against gravity or with resistance bands as appropriate. Exercise will then move to the open gym, where patients utilize endurance equipment of their choosing, such as a treadmill or recumbent bicycle. As with traditional PR, participants will be given online education videos regarding lung health to complete at home, with a supplementary video on breathing techniques to reduce atelectasis from pain. **Name:** Pulmonary Rehab **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Acceptability and feasibility will be documented by percent of those eligible enrolling in the study. **Measure:** Proportion of patients determined eligible who enroll in the study **Time Frame:** Through study completion, approximately 2 years **Description:** Acceptability and feasibility will be determined by the proportion of pulmonary rehab sessions completed during this condensed pulmonary rehab program **Measure:** Average Pulmonary Rehab sessions completed **Time Frame:** The 14 day (up to 21 day) intervention period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 years or older * Physician diagnosis of COPD * Lung nodule that is deemed highly suspicious for lung cancer based on: nodule characteristics, risk factors, CT-PET avidity, previous biopsy results, and assessment by LMDC physicians specializing in lung cancers * Eligible for surgical resection * Stage I, II, IIIa lung cancer with plan for lobectomy, pneumonectomy, or wedge resection * Current cigarette smoking ≥5 cigarettes per day * Willing to attempt smoking cessation during prehab period * Willing to take nicotine replacement therapy (NRT) and varenicline * Able to attend PR at UVMMC for 2, one-hour sequential sessions for a total of 16 sessions over 8 days in a 2-week time frame * Willing and able to provide informed consent; ability determined by study physician and/or LMDC treatment physicians Exclusion Criteria: * Unable to safely participate in PR due to unstable cardiac disease, unstable peripheral vascular disease, musculoskeletal disease that would prevent exercise, significant psychiatric or neurocognitive disease that would limit ability to exercise safely in a group setting as determined by the study physician and/or LMDC treatment physicians * Ineligible for surgical resection (including suspicion for metastatic disease) as determined by the study physician and/or LMDC treatment physicians * Inability to consistently attend PR over a 2-week period * Pregnancy, per patient self-report * Active or recent participation in another clinical trial that, in the opinion of the investigator would impact outcomes measured in this study * Any other condition in the opinion of the investigator/study physician and or LMDC treatment physicians that would jeopardize patient safety or integrity of research results **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Olivia J Garrow, MS, RDN **Phone:** 802-847-2160 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sophie Macner **Phone:** 802-847-2193 **Role:** CONTACT #### Locations **Location 1:** **City:** Burlington **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Olivia J Garrow, MS, RDN - **Phone:** 802-847-2160 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Sophie Macner, BS - **Phone:** 802-847-2193 - **Role:** CONTACT ***Contact 3:*** - **Name:** Katherine Menson, DO - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Anne Dixon, MD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Abraham Sender, PA-C - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Hannah Kooperkamp, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** University of Vermont Medical Center **State:** Vermont **Status:** RECRUITING **Zip:** 05401 ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-14 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 601853 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-24T14:57 - Date: 2024-05-14 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 374554 - Type Abbrev: ICF - Upload Date: 2024-05-24T14:57 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: HIGH - As Found: Obstructive Pulmonary Disease - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: HIGH - As Found: Chronic Obstructive Pulmonary Disease - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432959 **Acronym:** PAPA **Brief Title:** Incorporating Positive Affect Promoting Activities Into Cognitive Behavioral Therapies **Official Title:** Incorporating Positive Affect Into Cognitive Behavioral Therapy for Depression and Dialectical Behavior Therapy for Borderline Personality Disorder and Severe Emotion Dysregulation #### Organization Study ID Info **ID:** 2022B0257 #### Organization **Class:** OTHER **Full Name:** Ohio State University ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2022-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2023-03-22 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ohio State University #### Responsible Party **Investigator Affiliation:** Ohio State University **Investigator Full Name:** Jennifer Cheavens **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In this study, the investigators will test whether the incorporation of positive affect promoting activities in treatment sessions improves outcomes in the context of CBT for depression and DBT for problems of emotion dysregulation. In clinics focused on each of these treatments, the investigators will evaluate these treatments with and without the addition of positive affect promoting activities. **Detailed Description:** The investigators will randomize participants to treatment with or without positive affect promoting activities in two samples of adults with emotional disorders participating in a form of cognitive behavioral therapy. One sample will be drawn from a clinic providing CBT for depression and the other will be drawn from a clinic providing dialectical behavior therapy. This study is a two-clinic randomized clinical trial. Eligible participants will be randomized to standard treatment or standard treatment + positive affect promoting activities. A total of 50 participants (25 per condition) will be randomized in a clinic providing CBT for depression. A total of 40 (20 per condition) will be randomized in a clinic providing CBT for problems of emotion dysregulation. Treatment will be provided over 12 weeks in the CBT for depression clinic sample and 24 weeks in the DBT clinic sample. At pre-treatment, 4-weeks, and 12-weeks, participants will complete symptoms measures in addition to measures of diagnosis-relevant processes (e.g., rumination), personality, therapy skills, treatment engagement, and treatment history. Additionally, participants and providers will complete measures before and after each therapy session to assess alliance, engagement, symptoms, skills, and mood. Sessions will be recorded to later code psychotherapy process measures. CBT. Clients will participate in a course of CBT for depression. CBT consists of a series of structured, collaborative sessions with a focus on promoting behavioral activation and helping patients to re-evaluate unduly negative views (e.g., "I am worthless"). Treatment will be informed by the primary treatment manual for CBT of depression. Additional cognitive-behavioral treatment procedures for co-occurring conditions may be used as judged appropriate. Study personnel will provide treatment and all clinical assessments. Clinical supervision will be provided by a licensed psychologist. The protocol for CBT will be to have twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to maintain twice weekly sessions or switch to once weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. Clients will have the option of consulting with their therapist or another therapist (which would be likely when a therapist is no longer providing treatment for the study) for up to two booster sessions in the six months following their 12-week acute treatment period. DBT. Clients will participate in a six-month (24 to 26-week) course of DBT. DBT consists of weekly individual and group psychotherapy sessions that focus on enhancing skills in mindfulness, interpersonal effectiveness, emotion regulation, and distress tolerance. Individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week. At study end, participants who wish to continue treatment will be provided with referrals in the community or in the clinic, if therapists are available. Study personnel will provide treatment and all clinical assessments. Clinical supervision will be provided by a licensed psychologist. Recent evidence suggests that 6-months of DBT results in similar outcomes when compared to 12-months of DBT. The research group has demonstrated that DBT delivered in a training clinic with this protocol is associated with gains in the domains targeted in the treatment. Positive Affect Promoting Activities Participants will be randomized to either the Positive Affect Promotion Activities (PAPA) condition or the treatment-as-usual (TAU) condition. Patients in the TAU condition will receive either CBT or DBT as described above. Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in a positive affective promoting activities once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Following the first four weeks, therapists will work with clients to identify occasions to use positive affect induction procedures as part of between session coping strategies and as method to facilitate subsequent use of additional strategies (both in session and between sessions). The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively. Given that there are individual differences in the ways that people appraise various stimuli, it is important to be flexible in determining what might be an effective positive affect promoting activity for each participant. Some examples of positive affect promoting activities that might be incorporated into therapy sessions or between therapy sessions include: * Watch videos of animals (e.g., dogs, pandas, penguins) and babies (e.g., laughing, discovering) * Eat a piece of candy * Recall and describe a past positive experience (e.g., talk about success, interest / goal pursuit) * Describe the positive attributes of the participant * Engage in gratitude practice * Do something nice for someone (e.g., write thank you notes for deployed troops, notes of encouragement for children in the hospital, volunteer) * Listen to music * Draw or create * Practice mindfulness, including loving kindness meditations * Take a walk or dance * Watch clips of comedians * Go outside and sit in the sun * View pictures of loved ones/animals The in-session positive affect activities will last approximately five minutes. For the first four weeks, the positive affect activities will be completed at the beginning of the session. After that, therapists will look for opportunities to incorporate positive affect activities at "stuck points" or before learning a new skill in-session. Additionally, therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions. Participants and therapists will work together to identify activities that reliably lead to feeling joy, curiosity, pride, or love, for example. Then, therapists will work with participants to find opportunities to engage in these activities to help motivate themselves to engage in difficult tasks, learn new things, or regulate their emotions. ### Conditions Module **Conditions:** - Depression - Borderline Personality Disorder - Emotion Regulation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized Controlled Trial ##### Masking Info **Masking:** NONE **Masking Description:** Participants will be randomized to treatment as usual (i.e., CBT or DBT) or treatment-as-usual plus positive affect promoting activities (i.e., CBT with PAPA, DBT with PAPA). Randomization will occur within clinic (i.e., one clinic provides CBT, the other provides DBT). In the clinic providing CBT for depression, a total of 50 participants will be randomized (25 each to CBT or CBT with PAPA). In the clinic providing DBT, 40 participants will be randomized (20 each to CBT or CBT with PAPA). Given the treatments under investigation, neither the interventionist nor the participant could be kept unaware of condition. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in the TAU arm will receive either Cognitive Behavioral Therapy (CBT) or Dialectical Behavior Therapy (DBT), depending on eligibility. CBT will be twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to have once or twice weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. In DBT, individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week. **Intervention Names:** - Behavioral: Psychotherapy **Label:** Treatment as Usual **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in positive affective promoting activities. In session positive affective promoting activities are to be provided once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Clients will also be encouraged to utilize positive affect promoting activities between sessions. **Intervention Names:** - Behavioral: Psychotherapy, Positive Affect Promoting Activities - Behavioral: Psychotherapy **Label:** TAU + Positive Affect Promoting Activities **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - TAU + Positive Affect Promoting Activities **Description:** The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively. Some examples of positive affect promoting activities are: * Watch videos of animals and babies * Eat a piece of candy * Recall and describe a past positive experience * Describe the positive attributes of the participant * Engage in gratitude practice * Do something nice for someone The in-session positive affect activities will last approximately five minutes. For the first four weeks, the positive affect activities will be completed at the beginning of the session. After that, therapists will look for opportunities to incorporate positive affect activities at "stuck points" or before learning a new skill in-session. Additionally, therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions. **Name:** Psychotherapy, Positive Affect Promoting Activities **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - TAU + Positive Affect Promoting Activities - Treatment as Usual **Description:** Meet with treatment providers individually or in group to learn skills to address symptoms associated with depression and emotion dysregulation **Name:** Psychotherapy **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** 24-item self-report assessment of BPD features, will be used as an outcome measure for those in the DBT clinic. Each item is rated as "false," "slightly true," "mainly true," or "very true." Higher scores suggest more severe BPD features. **Measure:** Change in Personality Assessment Inventory - Borderline Personality Disorder Subscale **Time Frame:** 12 weeks **Description:** 100 item self-report measure of personality traits, including specifically for this study antagonism, neuroticism, and disinhibition. Each item is rated on a scale from 0 - 3 with higher scores reflecting more of a given trait. **Measure:** Change in Personality Inventory for DSM-5 - Faceted Brief Form **Time Frame:** 12 weeks #### Primary Outcomes **Description:** 16 item self-report assessment of symptoms of depression with each item scored on a 0-3 scale. Higher scores indicate more severe symptoms of depression. **Measure:** Weekly Change in Quick Inventory of Depressive Symptoms, Self-Report **Time Frame:** weekly over 12 weeks **Description:** 20 item self-rated assessment of positive and negative affect in the moment with each item scored on a 1-9 scale. Higher scores reflect higher levels of affect. **Measure:** Weekly Change in Positive and Negative Affect Schedule **Time Frame:** weekly over 12 weeks #### Secondary Outcomes **Description:** Measure developed for this study to assess use, understanding, and confidence in using therapy skills. There are seven items, each rated on a scale of 1-7. Higher scores indicate that the participant more fully understood the skills taught in session and is confident they will be able to use the skills outside of session. **Measure:** Weekly Change in Impressions of Skills Scale **Time Frame:** weekly over 12 weeks **Description:** 6 item questionnaire used to assess expectations of treatment with four items measuring confidence or expectations for the treatment (scored 1 - 9) and two items assessing anticipated improvement in symptoms (scored 0 - 100%). Higher scores reflect more confidence and expected improvement. **Measure:** Change in Credibility/Expectancy Questionnaire **Time Frame:** 4 weeks **Description:** Completed by both participants and providers to assess quality of the therapeutic relationship. This scale has 12-items and each is scored 0 - 6. Higher scores reflect a better therapeutic relationship. **Measure:** Weekly Change in Working Alliance Inventory **Time Frame:** weekly for 12 weeks ### Eligibility Module **Eligibility Criteria:** Clinic-specific inclusion criteria are as follows. For the clinic providing CBT for depression, participants must meet criteria for a diagnosis of major depressive disorder according to Diagnostic and Statistical Manual-5 (DSM-5). They must also be able to attend in-person sessions or have access to a reliable internet connection to participate in virtual sessions. For the clinic providing DBT, participants must evidence severe emotion dysregulation defined as (1) meeting criteria for borderline personality disorder (BPD) or (2) elevated indicators of borderline personality pathology defined as average scores of 1.5 on the Personality Inventory for DSM-5 (PID-5) Negative Affectivity scale and 1.25 on the Antagonism scale and/or 1.25 on the Disinhibition scale. They must also be willing and able to attend in-person sessions. Across both clinics, the following inclusion and exclusion criteria will be applied: Inclusion Criteria: 1. 18 years old or older 2. residence in the state of Ohio 3. able and willing to give informed consent Exclusion Criteria: 1. current or past diagnosis of bipolar disorder or a psychotic disorder 2. presence of a psychiatric disorder other than Major Depressive Disorder (MDD) or BPD, if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered (including substance use disorders involving heroin, cocaine, and methamphetamine deemed inappropriate at pre-screening) 3. currently participating in a psychosocial treatment for an emotional disorder, including any individual psychotherapy 4. if on psychiatric medication, no changes to medication regimen (drugs or dosage) in the past month and no intention to modify medication regimen for the next 12 weeks 5. clear indication of secondary gain (e.g., court-ordered treatment) 6. current suicide risk of medical instability (e.g., low weight) to preclude treatment on an outpatient basis **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jennifer S Cheavens, PhD **Phone:** 614-247-6733 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Daniel R. Strunk, Ph.D. **Role:** CONTACT #### Locations **Location 1:** **City:** Columbus **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Daniel R Strunk, PhD - **Phone:** 614-688-4891 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Jennifer S Cheavens, PhD - **Phone:** 614-247-6733 - **Role:** CONTACT ***Contact 3:*** - **Name:** Daniel R Strunk, PhD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Jennifer S Cheavens, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Department of Psychology, The Ohio State University **State:** Ohio **Status:** RECRUITING **Zip:** 43210 ### IPD Sharing Statement Module **Description:** We will consider requests for data sharing, pending approval from our Institutional Review Board (IRB). **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2023-03-16 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form: ICF for Participants in the DBT Clinic - Size: 192105 - Type Abbrev: ICF - Upload Date: 2024-05-24T12:39 - Date: 2022-08-11 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form: ICF for Participants in the Depression Clinic - Size: 210104 - Type Abbrev: ICF - Upload Date: 2024-05-24T12:42 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M13462 - Name: Personality Disorders - Relevance: HIGH - As Found: Personality Disorder - ID: M5161 - Name: Borderline Personality Disorder - Relevance: HIGH - As Found: Borderline Personality Disorder - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000010554 - Term: Personality Disorders - ID: D000001883 - Term: Borderline Personality Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432946 **Brief Title:** Sensing-glove System in Manual Therapy **Official Title:** Effect of Two Facilitating Interventions on the Acceptability and Usability Towards a Sensing-glove System to Measure Force-time Characteristics of Spinal Manipulative Therapy: a Mixed-methods Cross-over Study #### Organization Study ID Info **ID:** UQTR_IP_Acceptabilite_2021 #### Organization **Class:** OTHER **Full Name:** Université du Québec à Trois-Rivières ### Status Module #### Completion Date **Date:** 2021-08-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-08-31 **Type:** ACTUAL #### Start Date **Date:** 2021-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Université du Québec à Trois-Rivières #### Responsible Party **Investigator Affiliation:** Université du Québec à Trois-Rivières **Investigator Full Name:** Isabelle Pagé **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this clinical trial is to assess manual therapists' attitudes towards using a sensing-glove system for measuring spinal manipulation force and to compare the effectiveness of two interventions in enhancing their attitudes. The primary questions it aims to address are: * Are manual therapists receptive to employing a sensing-glove system to measure the force applied during spinal manipulations on patients? * Can we enhance manual therapists' attitudes towards this system through either a brief informational video demonstration or a supervised practice session with the system? Researchers will compare the impact of a 7-minute informational video to that of a 20-minute supervised practice session to determine if manual therapists' attitudes towards the use of a sensing-glove while treating their patients can be positively influenced. Participants will: * Engage in a single experimental session. * Complete a questionnaire at the beginning of the experimental session. * Undergo one of the two interventions and promptly complete two questionnaires following this intervention. * Undergo the other intervention and promptly complete the same two questionnaires following this intervention. **Detailed Description:** This study aimed to evaluate manual therapists' acceptability of a sensing-glove system for measuring spinal manipulation's force-time characteristics and compare the effectiveness of two interventions in enhancing their acceptability and usability perception. Participants will undergo two acceptability-enhancing interventions in randomized order: a 7-minute informational video and a 20-minute supervised practice session. At the start of the session and after each intervention, the acceptability and perception of usability towards the system will be assessed. ### Conditions Module **Conditions:** - Spinal Manipulation **Keywords:** - Chiropractic - Manual therapy - Acceptability - Usability - Force-time characteristics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Participants will undergo two interventions consecutively, with the order of evaluation randomized. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will initially view a 7-minute informational video followed by a 20-minute supervised practice session with the sensing-glove system. Acceptability and usability perception will be assessed after each intervention. **Intervention Names:** - Other: Video - Other: Practice session **Label:** Video followed by practice **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will initially participate in a 20-minute supervised practice session with the sensing-glove system followed by viewing a 7-minute informational video. Acceptability and usability perception will be assessed after each intervention. **Intervention Names:** - Other: Video - Other: Practice session **Label:** Practice followed by video **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Practice followed by video - Video followed by practice **Description:** A 7-minute video demonstrating the sensing-glove system, how it can be used to assess manual therapy biomechanics, and its relevance in research and clinical contexts. The video was created by the research team via a voiceover PowerPoint presentation. **Name:** Video **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Practice followed by video - Video followed by practice **Description:** A 20-minute practice session during which participants received verbal information about the sensing-glove system. While wearing the sensing glove, participants performed palpation and manual therapy techniques (palpation, spinal mobilization/manipulation to the cervical and thoracic spine) on a human-sized manikin, guided by the researcher. **Name:** Practice session **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** French version of the questionnaire based on the extended version of the Unified Theory of Acceptance and Use of Technology (UTAUT2) **Measure:** Acceptability **Time Frame:** Immediately following each intervention and at baseline **Description:** French version of the System usability scale (F-SUS). **Measure:** Usability **Time Frame:** Immediately following each intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being a licensed chiropractor or a last-year intern in a University outpatient chiropractic clinic Exclusion Criteria: * Reported any upper limb injury preventing them from executing manual therapies during the time of the study * Previous experience with the sensing-glove system **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Trois-Rivières **Country:** Canada **Facility:** Université du Québec à Trois-Rivières **State:** Quebec **Zip:** G8Z 4M3 #### Overall Officials **Official 1:** **Affiliation:** Université du Québec à Trois-Rivières **Name:** Isabelle Pagé, DC, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432933 **Acronym:** OXYBAR **Brief Title:** Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery **Official Title:** Comparison of Apnea-Hypopnea Index, in Patients With Potentially Undiagnosed Obstructive Sleep Apnea, Treated With or Without Preventive Oxygen Therapy, During the First Night After Bariatric Surgery #### Organization Study ID Info **ID:** 2023-2352 #### Organization **Class:** OTHER **Full Name:** Rijnstate Hospital ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-03 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Rijnstate Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The best perioperative strategy for obstructive sleep apnea (OSA) in bariatric surgery remains unclear. A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. However it is unknown what if preventive oxygen therapy is necessary. The goal of this trial is to compare the Apnea-Hypopnea Index (AHI) in participants with or without preventive oxygen therapy. Methods: Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B: Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention). **Detailed Description:** Rationale: The prevalence of obstructive sleep apnea (OSA) in the bariatric surgery population is high and mostly undiagnosed. The best perioperative strategy to manage sleep apnea in bariatric patients remains unclear. A recent study found that monitoring patients with pulsoximetry and giving them preventive oxygen therapy during the first postoperative night is safe and cost effective. In a population with patients with OSA but without obesity, no significant difference in apnea hypopnea index (AHI) was found between patients with and without oxygen therapy during the first postoperative night. The question was raised if preventive oxygen therapy during the first postoperative night after bariatric surgery is needed. Objective: The primary objective of this study is to compare AHI in patients with potentially undiagnosed OSA, treated with or without preventive oxygen therapy, during the first night after bariatric surgery. The secondary objective of this study is to compare sleep architecture in these patients Study design: This is a randomized controlled non-inferiority trial consisting of two arms; Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention). Study population: Patients scheduled for primary bariatric surgery without treated OSA Intervention: During the first postoperative night at the hospital patients in intervention arm B will not receive preventive oxygen therapy. Main study parameters/endpoints: Primary endpoint is AHI and secondary endpoints are 30 days complications rate, nursing intervention rate and parameters for sleep architecture and sleep related breathing, score of the Epworth Sleepiness Scale (ESS) and STOP BANG. ### Conditions Module **Conditions:** - Obstructive Sleep Apnea - Obesity - Bariatric Surgery Candidate ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 152 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: No preventive oxygen therapy (2L) **Label:** Without preventive oxygen therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Preventive oxygen therapy (2L) standard care **Label:** With preventive oxygentherapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Without preventive oxygen therapy **Description:** Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery. **Name:** No preventive oxygen therapy (2L) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - With preventive oxygentherapy **Description:** Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care. **Name:** Preventive oxygen therapy (2L) standard care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** AHI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms, the higher the AHI the more severe the sleep apnea **Measure:** Apnea-Hypopnea Index (AHI) **Time Frame:** First postoperative night #### Secondary Outcomes **Description:** All complication will be scored and will be compared between both arms **Measure:** Complication rate **Time Frame:** Until 30 days after surgery **Description:** Nursing interventions will be scored on a form and the number of nursing interventions will be compared between both arms **Measure:** The number of nursing interventions **Time Frame:** First postoperative night **Description:** e.g. waking up the patient or starting or increasing oxygen therapy/flow, this will be compared between both arms. **Measure:** Type of nursing interventions **Time Frame:** First postoperative night **Description:** ODI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Oxygen Desaturation Index (ODI) **Time Frame:** First postoperative night **Description:** AHI during REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** AHI during Rapid Eye Movement (REM) sleep **Time Frame:** First postoperative night **Description:** RDI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Respiratory disturbance index (RDI) **Time Frame:** First postoperative night **Description:** Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Mean saturation **Time Frame:** First postoperative night **Description:** Mean saturation during desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Mean saturation during desaturations, **Time Frame:** First postoperative night **Description:** Number of desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Number of desaturations **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Percentage of saturation <90% **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Percentage of saturation <88% **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Percentage of saturation <85% **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Percentage of saturation <80% **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Percentage of saturation <70% **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Time (minutes) of saturation <90% **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Time (minutes) of saturation <88% **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Time (minutes) of saturation <85% **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Time (minutes) of saturation <80% **Time Frame:** First postoperative night **Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Time (minutes) of saturation <70% **Time Frame:** First postoperative night **Description:** Total sleep time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Total sleep time (minutes) **Time Frame:** First postoperative night **Description:** Percentage of REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Percentage of REM sleep in total sleep time **Time Frame:** First postoperative night **Description:** Percentage of Deep sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Percentage of Deep sleep in total sleep time **Time Frame:** First postoperative night **Description:** Percentage of light sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Percentage of light sleep in total sleep time **Time Frame:** First postoperative night **Description:** Percentage of awake time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms **Measure:** Percentage of awake time **Time Frame:** First postoperative night ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Undergo primary bariatric surgery (RYGB or SG) * Speak and read the Dutch language Exclusion Criteria: * Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding) * Same-day discharge after bariatric surgery * Diagnosed OSA with treatment (CPAP, oral appliances) * Professional drivers * Use of alpha blockers * Unable to speak or read the Dutch language **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Claudia Berends, Msc **Phone:** +31880055970 **Role:** CONTACT #### Locations **Location 1:** **City:** Elst **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Claudia Berends - **Phone:** +31880055970 - **Role:** CONTACT **Country:** Netherlands **Facility:** Vitalys **Status:** RECRUITING **Zip:** 6662 NC #### Overall Officials **Official 1:** **Affiliation:** Rijnstate Hospital **Name:** Eric Hazebroek, Prof.dr. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012818 - Term: Signs and Symptoms, Respiratory - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M4361 - Name: Apnea - Relevance: HIGH - As Found: Apnea - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: HIGH - As Found: Obstructive Sleep Apnea - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001049 - Term: Apnea - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000020181 - Term: Sleep Apnea, Obstructive ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432920 **Acronym:** ResWave **Brief Title:** A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study **Official Title:** A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study #### Organization Study ID Info **ID:** RW-CIP 1.2 #### Organization **Class:** INDUSTRY **Full Name:** Elevre Medical Ltd. ### Status Module #### Completion Date **Date:** 2024-01-26 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-26 **Type:** ACTUAL #### Start Date **Date:** 2023-07-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Beacon Hospital #### Lead Sponsor **Class:** INDUSTRY **Name:** Elevre Medical Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this exploratory clinical trial is to evaluate the initial clinical safety and performance of a prototype wearable chest wall vibration (CWV) device intended to relieve exertional dyspnea in adults with Chronic Obstructive Pulmonary Disease. The main questions it aims to answer are: * Can CWV be delivered safely to participants via a wearable device? * Is there evidence of an effect on participant-reported dyspnea, endurance time and other measures of cardiorespiratory function? Participants will undergo two cycle-ergometer exercise testing sessions while wearing the prototype wearable device. The device will be active in one session (intervention) and inactive in the other (control). The order in which intervention or control occurs will be randomised. Researchers gather data relating to adverse events, device deficiencies, participant-reported symptom severity, endurance time and measures of cardiorespiratory function recorded via standard CPET apparatus. **Detailed Description:** The purpose of this Clinical Investigation is to evaluate the device design in a small number of human subjects with respect to initial clinical safety, and to gather preliminary data regarding the effect of the device on patient reported dyspnoea and physiological measures of cardiorespiratory function. This will facilitate planning of further steps of device development and validation, guide design modifications and define parameters for a future pivotal clinical investigation. The investigational device is at Pilot stage of Clinical Development, and the proposed Clinical investigation is a first-in-human exploratory study. It is not a superiority, non-inferiority, or equivalence study. The primary objective of this Clinical Investigation is to evaluate the investigational device with respect to initial clinical safety when used by subjects with Chronic Obstructive Pulmonary Disease during physical exertion in the form of cycle ergometer-based Cardiopulmonary Exercise Testing. The secondary objective of this Clinical Investigation is to gather preliminary data regarding the effect of the device on patient-reported dyspnoea and physiological measures of cardiorespiratory function. Each subject will attend the investigation site for a Pre-Study visit during which formal written consent will be obtained, clinical history and medications will be reviewed as part of standard CPET pre-assessment, and enrolment in the Clinical Investigation will be complete. An initial Incremental Cardiopulmonary Exercise Testing (CPET) session will then be conducted to determine baseline Peak Work Rate capacity. This is necessary so that the intensity of CPET that will be required to achieve 75% of each subject's individual Peak Work Rate capacity can be determined. Peak Work Rate capacity will be defined as the highest work rate that the Subject is able to maintain for ≥30 seconds. Following initial CPET, subjects will return for device testing on a non-consecutive day. Each subject will undergo 2 study arms during this visit: the Intervention (ResWave) and Control arms, in the random order. Both arms will be conducted on the same day, with a recovery period of 60 minutes between each arm. Subjects will undergo sub-maximal exercise testing at a Constant Work Rate (CWR) of 75% of their peak work rate capacity in both arms. Borg CR10 scores will be recorded at 2 minute intervals throughout. Endurance time will be recorded at test completion. Adverse Events will be recorded throughout testing and at 72-hour follow-up via phone call. Device Deficiencies will be recorded throughout testing. ### Conditions Module **Conditions:** - Chronic Obstructive Pulmonary Disease - Dyspnea **Keywords:** - dyspnea - COPD - chronic obstructive pulmonary disease - cpet - cardiopulmonary exercise testing - chest wall vibration ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Participants undergo constant-work rate cardiopulmonary exercise testing 2 times: once while wearing the active prototype device (intervention) and once wearing the inactive prototype device (control). Order of intervention/control is randomised. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In-phase Chest Wall Vibration worn and active during constant work rate exercise testing. **Intervention Names:** - Device: ResWave **Label:** ResWave **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In-phase Chest Wall Vibration worn and inactive (off) during constant work rate exercise testing. **Intervention Names:** - Device: ResWave **Label:** Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control - ResWave **Description:** Prototype wearable in-phase chest wall vibration device **Name:** ResWave **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Adverse Events during or following use of the prototype device and/or exercise testing protocol **Measure:** Adverse Events **Time Frame:** 72 hours **Description:** Performance data of the device during use **Measure:** Device Deficiencies **Time Frame:** During active use in exercise testing #### Secondary Outcomes **Description:** Borg Category-Ratio scale (Borg CR10). Scale from 0 (lowest intensity, better) to 10 (maximal intensity, worse). **Measure:** Dyspnea severity **Time Frame:** Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime. **Description:** Exercise testing endurance time **Measure:** Endurance time **Time Frame:** Duration of exercise testing **Description:** Whether participant stopped exercise testing due to dyspnea or other reason **Measure:** Reason for stopping **Time Frame:** During exercise testing **Description:** Minute Ventilation in millilitres/minute (mL/min) **Measure:** Minute Ventilation (VE) **Time Frame:** During exercise testing **Description:** Heart rate in beats per minute (BPM) **Measure:** Heart Rate (HR) **Time Frame:** During exercise testing **Description:** Oxygen Pulse (VO2/HR) in millilitres/minute (mL/min) **Measure:** Oxygen Pulse **Time Frame:** During exercise testing **Description:** Oxygen Consumption (VO2) in millilitres/minute (mL/min) **Measure:** Oxygen Consumption **Time Frame:** During exercise testing **Description:** Carbon Dioxide Production (VCO2) in millilitres/minute (mL/min) **Measure:** Carbon Dioxide Production **Time Frame:** During exercise testing **Description:** Work (W) in watts **Measure:** Work **Time Frame:** During exercise testing **Description:** Tidal Volume in Litres (L) at body temperature and pressure saturated (BTPS) **Measure:** Tidal Volume (VT) **Time Frame:** During exercise testing **Description:** Respiratory Quotient (CO2 produced / O2 consumed; no unit as it is a ratio value) **Measure:** Respiratory Quotient (RQ) **Time Frame:** During exercise testing **Description:** End-tidal carbon dioxide tension (PETCO2) in millimetres of mercury (mmHg) **Measure:** End-tidal carbon dioxide tension (PETCO2) **Time Frame:** During exercise testing **Description:** End-tidal oxygen tension (PETO2) in millimetres of mercury (mmHg) **Measure:** End-tidal oxygen tension (PETO2) **Time Frame:** During exercise testing **Description:** Oxygen Saturation (SpO2) (%, percentage) **Measure:** Oxygen Saturation (SpO2) **Time Frame:** During exercise testing **Description:** Respiratory Reserve in Litres **Measure:** Respiratory Reserve **Time Frame:** During exercise testing **Description:** Expiration Time in seconds **Measure:** Expiration Time **Time Frame:** During exercise testing ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with FEV1 / FVC ratio of \< 75% and deemed clinically stable * Moderate to severe airflow limitation on Spirometry (FEV1: 30 to 75% predicted) * Pulmonary Function Testing completed in the last 6 months Exclusion Criteria: * Active pulmonary infection or exacerbation within last 6 weeks * Unstable cardiac disease - cardiac intervention, change in symptoms or medication within last 6 weeks * BMI \> 35 * Receiving domiciliary oxygen therapy * Diagnosis of COVID-19 within the last 12 weeks or persistent symptoms directly attributable to previous COVID-19 infection * Presence of comorbid condition that is deemed to be a significant contributor to dyspnoea: Heart Failure, Chronic Thromboembolic Disease, Neuromuscular Disease, Primary Pulmonary Hypertension * Pulmonary Embolism in last 3 months * Abdominal or Thoracic surgery in last 3 months * Pneumothorax in last 6 months * Active malignancy * Active chest wall pain, active skin condition or open wound on thorax * Pregnant or breastfeeding * Women of child-bearing age (premenopausal, under age 50, or without previous sterilisation surgery) * Any implantable electronic device * On anticoagulants or with known history of coagulopathy * Any absolute or relative contraindication to CPET testing * Disability or comorbid condition that prevents exercise training and/or use of CPET apparatus and/or wearing the investigational device * Previous experience of Chest Wall Vibration therapies for relief of breathlessness * Currently enrolled in any other clinical trial or research study * People deemed to be incapable of giving consent, or with reduced capacity to consent or diminished autonomy as a result of mental or cognitive impairment, or deemed otherwise vulnerable on clinical grounds **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Sandyford **Country:** Ireland **Facility:** Beacon Hospital **State:** Dublin 18 **Zip:** D18 AK68 #### Overall Officials **Official 1:** **Affiliation:** Beacon Hospital **Name:** Professor Seamus Linnane (MB BCh BAO FRCP FRCPI) **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** At present there is no plan to share individual participant data (IPD). As this is a novel medical device prototype currently undergoing development, IPD sharing could undermine future research and development activities relating proprietary aspects of the technology. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000012120 - Term: Respiration Disorders - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7591 - Name: Dyspnea - Relevance: HIGH - As Found: Dyspnea - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Pulmonary Disease - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: HIGH - As Found: Obstructive Pulmonary Disease - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: HIGH - As Found: Chronic Obstructive Pulmonary Disease - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000029424 - Term: Pulmonary Disease, Chronic Obstructive - ID: D000004417 - Term: Dyspnea ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432907 **Brief Title:** StereoEEG Motor Neuronal Potentials Decoding **Official Title:** Decoding of Neuronal Potentials Associated With Motor Performance and Motor Imagery Obtained Using Intracranial stereoEEG Electrodes #### Organization Study ID Info **ID:** Stereo-iBCI #### Organization **Class:** OTHER_GOV **Full Name:** Research Center of Neurology, Russia ### Status Module #### Completion Date **Date:** 2026-12-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-22 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Institute of Higher Nervous Activity and Neurophysiology of RAS #### Lead Sponsor **Class:** OTHER_GOV **Name:** Research Center of Neurology, Russia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goals of this study are (1) to evaluate the rate of stereoEEG brain-computer interface (BCI) classification accuracy and (2) to collect the dataset of neuronal signals recorded from stereoEEG electrodes during motor performance, motor imagery or brain-computer interface control. The study enrolls hospitalised patients suffering from resistant epilepsy with already implanted intracranial stereoEEG electrodes for medical reasons (i.e. for preoperative localization of the epileptogenic foci). The number and location of electrodes are determined solely for the clinical purposes of stereoEEG monitoring and are not related to the protocol of the current study. After obtaining informed consent to participate in the study, each patient will participate in one experimental session lasting no more than 60 minutes, recording brain signals associated with hand movement, motor imagery, and BCI control. All tasks and instructions presented during the study session are not pro-epileptogenic and cannot provoke an epileptic attack. The experiments will take place in the patient's room, without interruption of observation by the department's medical staff. The data recorded in this study will be used to improve or develop new algorithms for decoding motor signals from deep brain structures for their potential use in invasive BCIs. ### Conditions Module **Conditions:** - Drug Resistant Epilepsy - Brain-Computer Interfaces **Keywords:** - Brain-Computer Interface - Motor Imagery - Motor Performance - Intracranial Electroencephalography ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each patient will participate in one experimental session lasting no more than 60 minutes, recording brain signals associated with hand movement, motor imagery, and brain-computer interface (BCI) control. **Intervention Names:** - Other: motor tasks **Label:** StereoEEG **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - StereoEEG **Description:** During the study session, the patient will sit at a table in front of a computer monitor. The stereoEEG electrodes will be connected to the Neurovisor-BMM52 electroencephalograph (Medical Computer Systems, Russia) and to a computer with a software for recording and decoding brain signals (BCI classifier). One microsensor (Ascension TrekStar, Ascension Technology, USA) and two disposable cutaneous electrodes (connected to the Neurovisor-BMM52 system) will be put on each patient's hand for electromyogram recording. The session consists from 3 blocks (1-3). The participant is asked to: 1. execute simple motor tasks (thumbs up, open hand or clench hand into fist - 30 times with each hand with 5-second brakes), according to the instruction on the computer screen; 2. to imagine the same movements - 30 times with each hand with 5-second brakes; 3. to imagine the same movements with the feedback (brain-computer interface control). The blocks are separated by 5-minute brakes. **Name:** motor tasks **Other Names:** - motor execution, motor imagery, brain-computer interface control with motor imagery paradigm **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The accuracy of BCI classifier in neural signal recognition - the proportion (%) of cases with correct identification of the task among all presentations of the corresponding command. Classification accuracy will be evaluated as ratio of correct BCI classifier answers averaged over all classes, based on confusion matrix obtained during online moving window classification. **Measure:** Rate of BCI classification recall **Time Frame:** During the procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * male and female patients who have had stereoEEG electrodes implanted for medical reasons; * voluntary informed consent to participate in the study; * age from 18 to 70 years. Exclusion Criteria: * patient refusal to participate in the study; * cognitive impairment that prevents following the study instructions; * severe visual impairment that does not allow viewing visual instructions on a computer screen; * upper limb paresis or other motor disorders; * pain in the hand of any etiology; * any acute diseases, exacerbation of chronic diseases, acute life-threatening conditions; * occurrence of an epileptic attack during the experiment. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Olesya A Mokienko, MD PhD **Phone:** +74953747776 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Roman Kh Lyukmanov, MD PhD **Phone:** +74953747776 **Role:** CONTACT #### Locations **Location 1:** **City:** Moscow **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Natalia A Suponeva, MD - **Phone:** +79161894988 - **Role:** CONTACT ***Contact 2:*** - **Name:** Olesya A Mokienko, MD PhD - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Roman Kh Lyukmanov, MD PhD - **Role:** SUB_INVESTIGATOR **Country:** Russian Federation **Facility:** Research center of neurology, Department of neurorehabilitation and physiotherapy **Status:** RECRUITING **Zip:** 125367 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004827 - Term: Epilepsy - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7983 - Name: Epilepsy - Relevance: LOW - As Found: Unknown - ID: M369 - Name: Drug Resistant Epilepsy - Relevance: HIGH - As Found: Drug Resistant Epilepsy - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000069279 - Term: Drug Resistant Epilepsy ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432894 **Brief Title:** Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam **Official Title:** Performance Evaluation of Analgesia Nociception Index (ANI) in Patients Under General Anaesthesia With Remimazolam: a Prospective Observational Study #### Organization Study ID Info **ID:** Ilsan_Cha_2023-04-003-005 #### Organization **Class:** OTHER **Full Name:** Catholic Kwandong University ### Status Module #### Completion Date **Date:** 2025-06-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Catholic Kwandong University #### Responsible Party **Investigator Affiliation:** Catholic Kwandong University **Investigator Full Name:** Jungmin Lee **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam. ### Conditions Module **Conditions:** - Pain Measurement **Keywords:** - Remimazolam - Remifentanil - Analgesia Nociception Index (ANI) ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 20 Months ### Arms Interventions Module #### Arm Group 1 **Description:** Patients * aged 20-80 years under general anaesthesia with remimazolam * scheduled to undergo robotic surgery * in American Society of Anesthesiologists physical class 1, 2 or 3 **Intervention Names:** - Combination Product: Analgesia Nociception Index, remimazolam **Label:** observation ### Interventions #### Intervention 1 **Arm Group Labels:** - observation **Description:** The purpose of this study is to determine the validity of ANI in patients undergoing surgery with remifentanil and remimazolam. During this study, remimazolam infusion rate is determined by the pharmacopoeia. Remifentanil infusion rate is determined based on the patient's vital signs, systemic status and pain levels. And remifentanil is administrated via targeted infusion control using the Minto model. ANI scores, vital signs, remifentanil infusion rate are collected at predetermined time points according to the protocol from the start to the end of the surgery. **Name:** Analgesia Nociception Index, remimazolam **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Other Outcomes **Description:** When there are changes of heart rate or blood pressure more than 20% from baseline within 5 minutes of pain stimulus **Measure:** Hemodynamic change **Time Frame:** within 5 minutes of pain stimulus #### Primary Outcomes **Description:** A value indicating the degree of pain calculated by ANI's algorithm **Measure:** ANI values **Time Frame:** During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change) #### Secondary Outcomes **Description:** Because the ANI value is calculated using the change in HR, it is measured to correlate the change in ANI value with the change in HR due to pain. **Measure:** Heart Rate (HR) change **Time Frame:** Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation **Description:** The PSI is an indicator of a patient's depth of sedation and is calculated based on EEG, which can change in response to painful stimuli. The PSI score is expressed as a number between 0 and 100, and it is usually recommended to maintain under 60 during surgery. An increase in the PSI score can indicates the degree of pain stimulus and can be used as an indicator to assess the validity of the ANI value. **Measure:** Patient state index (PSI) change **Time Frame:** Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation **Description:** When a patient feels pain, it stimulates the autonomic nervous system to change blood pressure. This change is measured to determine how much pain the patient is feeling **Measure:** Blood Pressure change **Time Frame:** Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation **Description:** Remimazolam is a sedative. The infusion rate of remimazolam correlates with sedation level. And it is measured to determine if sedation level correlates with ANI values when pain stimuli are given. **Measure:** Remimazolam infusion rate **Time Frame:** During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change) **Description:** Remifentanil is an opioid and can affect pain levels when given a pain stimulus. **Measure:** Effect site concentration of remifentanil **Time Frame:** During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients * aged 20-79 years under general anaesthesia with remimazolam * scheduled to undergo robotic surgery * in American Society of Anesthesiologists physical class 1, 2 or 3 * voluntarily agree in writing to participate in this clinical study Exclusion Criteria: * Conditions affecting the autonomic nervous system * other conditions or disease that may cause acute or chronic pain * the NRS before induction of anesthesia is 1 or over * When taking medications that may affect the autonomic nervous system * In other cases where the investigator deems the subject unsuitable for this trial **Maximum Age:** 79 Years **Minimum Age:** 20 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients who visit the hospital and undergo surgery ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jungmin Lee **Phone:** 821041929159 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Joohyun Lee **Phone:** 821074200912 **Role:** CONTACT #### Locations **Location 1:** **City:** Incheon **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jungmin Lee, MD - **Phone:** 821041929159 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Joohyun Lee, MD - **Phone:** 821074200912 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Catholic-Kwandong University, School of Medicine **Status:** RECRUITING **Zip:** 22711 #### Overall Officials **Official 1:** **Affiliation:** Ilsan Cha hospital **Name:** Young Joo **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M1696 - Name: Remifentanil - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432881 **Brief Title:** Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE) **Official Title:** Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE) #### Organization Study ID Info **ID:** GOOD0001 #### Organization **Class:** INDUSTRY **Full Name:** Masimo Corporation ### Status Module #### Completion Date **Date:** 2025-02-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02-21 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-02-23 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Masimo Corporation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area. ### Conditions Module **Conditions:** - Hypoxemia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 152 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All subjects are enrolled into this arm and will have Sp02 measurements obtained. **Intervention Names:** - Device: RD SET Sensor **Label:** RD SET Sensor **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - RD SET Sensor **Description:** All subjects are enrolled into this arm and will have Sp02 measurements obtained. **Name:** RD SET Sensor **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The study is designed to evaluate the performance of Masimo RD SET SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area. SpO2 accuracy will be determined by calculating the ARMS value which will be reported as percent of oxygen saturated hemoglobin. **Measure:** Investigation of skin pigmentation effect on performance of Masimo pulse oximetry **Time Frame:** Approximately 30 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subject is 18 years of age or older. * Subject is receiving care in an intensive care unit. * Subject with an arterial catheter in place. * Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air Exclusion Criteria: * Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity). * Subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.). * Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care. * Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied. * Subjects with known allergic reactions to adhesive tapes. * Subjects with arterial catheter placed in a lower extremity. * Subjects not suitable for the investigation at the discretion of the investigator or the clinical team. **Maximum Age:** 89 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chelsea Frank **Phone:** 949-297-7000 **Role:** CONTACT #### Locations **Location 1:** **City:** Charleston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Chelsea Frank - **Phone:** 949-297-7000 - **Role:** CONTACT **Country:** United States **Facility:** Medical University of South Carolina **State:** South Carolina **Status:** RECRUITING **Zip:** 29425 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4185 - Name: Hypoxia - Relevance: HIGH - As Found: Hypoxemia - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000860 - Term: Hypoxia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432868 **Brief Title:** Solarplast (R) Supplementation Effects Following High-intensity Resistance Exercise **Official Title:** Effects of Solarplast (R) Supplementation on Biomarkers of Muscle Damage, Inflammation and Recovery of Physical Performance Following High-intensity Resistance Exercise #### Organization Study ID Info **ID:** 927 #### Organization **Class:** OTHER **Full Name:** Kent State University ### Status Module #### Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-17 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kent State University #### Responsible Party **Investigator Affiliation:** Kent State University **Investigator Full Name:** Adam Jajtner **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The primary goal of this investigation is to assess whether Solarplast (R) supplementation will improve recovery following heavy resistance exercise in active adults. The primary questions to be addressed are: Does Solarplast (R) decrease muscle damage and inflammation associated with heavy resistance exercise? Does Solarplast (R) reduce the decline in performance associate with heavy resistance exercise? Researchers will compare Solarplast (R) to a placebo (a look-alike substance that contains no active ingredients) to see if Solarplast (R) is effective at improving recovery. Participants will be asked to: Take Solarplast (R) or placebo daily for 4 weeks Visit the laboratory at least once per week to receive their supplement Report to the lab for 3 consecutive visits following supplementation to complete a heavy resistance training session and follow-up testing. ### Conditions Module **Conditions:** - Muscle Damage ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 100mg/day of Solarplast (R) supplementation (28 days). **Intervention Names:** - Dietary Supplement: Solarplast (R) **Label:** Solarplast (R) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 100mg/day of Placebo (maltodextrin (98.8%) and medium chain triglycerides (1.2%)). **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Solarplast (R) **Description:** Daily supplementation for 28 days prior to heavy resistance exercise. **Name:** Solarplast (R) **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Daily supplementation for 28 days prior to heavy resistance exercise. **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** Measure of Performance Change **Measure:** Rate of Muscular Fatigue **Time Frame:** Acute changes following exercise for 48 hours **Description:** Measure of Performance Change **Measure:** Rate of Muscular Fatigue **Time Frame:** Change in Resting Values over 4 weeks of supplementation **Description:** Marker of Muscle Damage **Measure:** Lactate Dehydrogenase Activity **Time Frame:** Acute changes following exercise for 48 hours **Description:** Circulating Marker of Stress **Measure:** Cortisol Concentration **Time Frame:** Acute changes following exercise for 48 hours **Description:** Circulating Marker of Stress **Measure:** Cortisol Concentration **Time Frame:** Change in Resting Values over 4 weeks of supplementation **Description:** Circulating Marker of Oxidative Stress **Measure:** Glutathione (GSH) Activity **Time Frame:** Change in Resting Values over 4 weeks of supplementation **Description:** Circulating Marker of Oxidative Stress **Measure:** Glutathione (GSH) Activity **Time Frame:** Acute changes following exercise for 48 hours **Description:** Circulating Marker of Oxidative Stress **Measure:** Total Antioxidant Capacity **Time Frame:** Change in Resting Values over 4 weeks of supplementation **Description:** Circulating Marker of Oxidative Stress **Measure:** Total Antioxidant Capacity **Time Frame:** Acute changes following exercise for 48 hours **Description:** Circulating Marker of Inflammation **Measure:** Interleukin 6 (IL-6) Concentration **Time Frame:** Change in Resting Values over 4 weeks of supplementation **Description:** Circulating Marker of Inflammation **Measure:** Interleukin 6 (IL-6) Concentration **Time Frame:** Acute changes following exercise for 48 hours **Description:** Circulating Marker of Inflammation **Measure:** Interleukin 10 (IL-10) Concentration **Time Frame:** Change in Resting Values over 4 weeks of supplementation **Description:** Circulating Marker of Inflammation **Measure:** Interleukin 10 (IL-10) Concentration **Time Frame:** Acute changes following exercise for 48 hours **Description:** Circulating Marker of Inflammation **Measure:** Tumor Necrosis Factor - alpha (TNFa) Concentration **Time Frame:** Change in Resting Values over 4 weeks of supplementation **Description:** Circulating Marker of Inflammation **Measure:** Tumor Necrosis Factor - alpha (TNFa) Concentration **Time Frame:** Acute changes following exercise for 48 hours **Description:** Measure of Performance Change **Measure:** Rate of Force Development **Time Frame:** Change in Resting Values over 4 weeks of supplementation **Description:** Measure of Performance Change **Measure:** Peak Muscle Force **Time Frame:** Acute changes following exercise for 48 hours **Description:** Measure of Performance Change **Measure:** Vertical Jump Height **Time Frame:** Change in Resting Values over 4 weeks of supplementation #### Primary Outcomes **Description:** Marker of Muscle Damage **Measure:** Creatine Kinase Activity **Time Frame:** Acute changes following exercise for 48 hours #### Secondary Outcomes **Description:** Marker of Muscle Damage **Measure:** Myoglobin Concentration **Time Frame:** Acute changes following exercise for 24 hours **Description:** Measure of Performance Change **Measure:** Vertical Jump Height **Time Frame:** Acute changes following exercise for 48 hours **Description:** Measure of Performance Change **Measure:** Mean Squat Velocity **Time Frame:** Acute changes following exercise for 48 hours **Description:** Measure of Performance Change **Measure:** Peak Isometric Muscle Force **Time Frame:** Acute changes following exercise for 48 hours **Description:** Measure of Performance Change **Measure:** Rate of Force Development **Time Frame:** Acute changes following exercise for 48 hours **Description:** Visual Analog Scale (1-100mm; low values indicate reduced soreness) **Measure:** Ratings of Perceived Soreness **Time Frame:** Acute changes following exercise for 48 hours **Description:** Visual Analog Scale (1-100mm; low values indicated reduced fatigue) **Measure:** Ratings of Perceived Fatigue **Time Frame:** Acute changes following exercise for 48 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Recreationally-active (participated in at least 2 weight training workouts per week over the previous year) and participates in at least 3h of total structured exercise/week as determined by the health and activity questionnaire. * Subject is judged by the Investigator to be healthy and free of any physical limitations (determined by health and activity questionnaire) * Subject has a body mass index of 18.0-34.9 kg/m2, inclusive * Subject is willing to maintain habitual diet throughout the study period * Subject is willing to abstain from dietary supplementation throughout the duration of the study. * Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators Exclusion Criteria: * Subject is currently or will be enrolled in another clinical trial. * Subject is a habitual consumer of tea/antioxidants defined as \> 8 oz/day of either green or black tea within the 14 days prior to the screening visit. * Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder. * Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer. * Subject is unable to perform physical exercise (determined by health and activity questionnaire) * Subject is engaged in an extreme diet including but not limited to, Atkins, South Beach, Intermittent Fasting, etc. * Subject is allergic to the study product or placebo * Subject is taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire) * Subject has any chronic illness that causes continuous medical care * Taking any type of prescription or over-the-counter medication including but not limited to corticosteroids, non-steroidal anti-inflammatory drugs, and antibiotics within the 14 days prior to the screening visit. **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Adam R Jajtner, PhD **Phone:** 330-672-0212 **Phone Ext:** 20212 **Role:** CONTACT #### Locations **Location 1:** **City:** Kent **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Adam R Jajtner, PhD - **Phone:** 330-672-0212 - **Phone Ext:** 20212 - **Role:** CONTACT **Country:** United States **Facility:** Kent State University - Exercise Science & Exercise Physiology **State:** Ohio **Status:** RECRUITING **Zip:** 44242 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432855 **Acronym:** GEDIPOP **Brief Title:** Genetic Determinants of the Antiviral Immune Response in Oceanian Populations **Official Title:** Genetic Determinants of the Antiviral Immune Response in Oceanian Populations #### Organization Study ID Info **ID:** 2022-035 #### Organization **Class:** INDUSTRY **Full Name:** Institut Pasteur #### Secondary ID Infos **Domain:** ID RCB **ID:** 2023-A02206-39 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Institut Pasteur #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Oceania's populations, including Melanesians, are paying a heavy price for dengue fever, which has been circulating actively in the region since the Second World War. In New Caledonia (NC), the incidence of dengue fever is higher among municipalities predominantly populated by Melanesians, suggesting that Melanesians may have an increased susceptibility to symptomatic dengue fever. Differences in antiviral immune responses between populations of different geographical origins are partly the result of population-specific immune regulatory variants. In turn, viruses have imposed considerable selective pressure on human populations. Although crucial to understanding their susceptibility to viral infections, the genetic determinants of the antiviral immune response of Oceanians remain to be characterized. In this context, we hypothesize that the genetic origin of Oceanians, and Melanesians in particular, has shaped their antiviral immune response and contributes to their greater susceptibility to certain viral infections. We aim to characterize the immune response to pathogens affecting the New Caledonian population, and in particular to dengue virus, of Melanesian and European populations, and to identify its genetic determinants. We will also explore whether saliva can be used as a non-invasive sample to study the seroprevalence of dengue in Oceanian populations. **Detailed Description:** Cross-sectional observational study with prospective sample and data collection Individuals will be identified from among eligible participants in the STEP-BSA21 and COVCAL studies. Information and consent Questionnaire, saliva collection on Oragene tube, buccal swabbing and 20 mL blood collection on CPT tube DNA extraction and low-coverage sequencing of participants' complete genomes And Isolation and in vitro stimulation of peripheral blood mononuclear cells (PBMCs) with dengue virus * single-cell RNA sequencing (scRNAseq) * multiplex quantification of cytokines and chemokines * bioinformatics analysis to identify genetic markers associated with a differential transcriptomic and secretory response to dengue virus stimulation. ### Conditions Module **Conditions:** - Virus **Keywords:** - dengue - immunity - genetics - Ocenian populations - New Caledonia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Saliva samples and 20 mL blood samples from individuals of Melanesian and European origin from NC **Intervention Names:** - Other: Blood collection - Other: saliva collection **Label:** Non-febrile adults of Melanesian and European origin **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-febrile adults of Melanesian and European origin **Description:** 20 ml-blood sample **Name:** Blood collection **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Non-febrile adults of Melanesian and European origin **Description:** saliva sample **Name:** saliva collection **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Identification by genomic techniques of expression Quantitative Trait Loci (eQTL) specifically associated with the innate immune response of Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin and stimulated in vitro by DENV. **Measure:** Identify the genetic determinants of the innate immune response to pathogens affecting the New Caledonian population, and in particular to the dengue virus in individuals of Melanesian and European origin. **Time Frame:** 3 years #### Secondary Outcomes **Description:** Low-coverage DNA sequencing of the complete genome of individuals of Melanesian and European origin. **Measure:** To describe the genetic diversity of Melanesian and European populations in NC in relation to the determinants of susceptibility to health problems affecting NC populations. **Time Frame:** 3 years **Description:** Quantification by single cell RNAseq techniques of differentially expressed transcripts in response to in vitro dengue virus stimulation by Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin. **Measure:** Characterizing the transcriptomic response to DENV in individuals of Melanesian and European origin. **Time Frame:** 3 years **Description:** Quantification by multiplex techniques of the concentration of cytokines and chemokines differentially secreted in response to in vitro stimulation by dengue virus by Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin. **Measure:** Characterize the cytokine and chemokine response to DENV in individuals of Melanesian and European origin. **Time Frame:** 3 years **Description:** Quantification by multiplex techniques of the concentration of cytokines and chemokines differentially secreted in response to in vitro stimulation by dengue virus by Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin. Multivariate analyses of the association of environmental factors collected during the inclusion visit (questionnaire and measurements) or during analyses conducted as part of the present research with the immune response targeting the dengue virus. **Measure:** Study the effect of environmental factors (smoking/non-smoking status, history of Cytomegalovirus or dengue virus infection, presence of diabetes, etc.) on the immune response to dengue virus. **Time Frame:** 3 years **Description:** Next-generation sequencing and analysis of the oral microbiome on a saliva sample **Measure:** Study the oral microbiome of individuals of Melanesian and European origin and analyze its association with the immune response to pathogens. **Time Frame:** 3 years **Description:** Luminex quantification of dengue virus antibodies in serum and saliva from Melanesian and European individuals. **Measure:** Determine whether history of dengue virus infection can be demonstrated by testing saliva for antibodies using the Luminex technique. **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult * Non-febrile * Self-declared member of the Melanesian or European community * Having given consent to participate in the study Exclusion Criteria: * People who have taken part in a clinical study in the last 6 months in which they were exposed to a health product as part of the investigation (pharmaceutical product or device or placebo). * People taking part in an ongoing clinical study * People declaring themselves to belong to two communities (e.g. people of mixed European and Melanesian descent) * Pregnant and breast-feeding women (in whom the immune response could be modified) * People with a long-term medical condition (as defined by the French social security system) that could have an effect on the immune response, excluding dengue risk factors prevalent in New Caledonia such as diabetes, overweight/obesity and hypertension. * Individuals with an acute infection (viral, bacterial or fungal) within 3 months of inclusion. * Chronic administration (for more than 14 days) of immunosuppressants or treatments affecting the immune system in the 6 months prior to inclusion. For corticosteroids, this corresponds to a dose equivalent to 20 mg/day of prednisone or equivalent for more than two weeks (inhaled or topical steroids are permitted). * Administration of a vaccine within 3 months prior to inclusion. * Administration of blood products or immunoglobulins within 3 months of inclusion. * People with known allergies to antibiotics, which could have an impact on the in vitro culture of PBMCs in the presence of antibiotics * Persons not intellectually capable of answering the questionnaire * Persons under guardianship, curatorship or any other legal incapacity **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Catherine Inizan, PhD **Phone:** +687 27 26 66 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Myrielle Dupont-Rouzeyrol, PhD **Phone:** +687 27 75 30 **Role:** CONTACT #### Locations **Location 1:** **City:** Nouméa **Contacts:** ***Contact 1:*** - **Name:** Marc Jouan, MD - **Role:** CONTACT **Country:** New Caledonia **Facility:** Institut Pasteur de Nouvelle-Calédonie **Zip:** 98 835 #### Overall Officials **Official 1:** **Affiliation:** Institut Pasteur de Nouvelle-Calédonie **Name:** Marc Jouan, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6913 - Name: Dengue - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: T1794 - Name: Dengue Fever - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432842 **Brief Title:** Knee Osteoarthritis and Rehabilitation **Official Title:** Knee Osteoarthritis and Lazer Therapy #### Organization Study ID Info **ID:** Karabuk-80 #### Organization **Class:** OTHER **Full Name:** Karabuk University ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-12-01 **Type:** ACTUAL #### Start Date **Date:** 2023-07-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-03-25 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Karabuk University #### Responsible Party **Investigator Affiliation:** Karabuk University **Investigator Full Name:** METEHAN YANA **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Osteoarthritis (OA) is a chronic degenerative disease of articular cartilage that causes hypertrophic changes in bone. OA is a non-inflammatory progressive musculoskeletal disease and is one of the most common degenerative diseases in the general population. OA is characterized by progressive cartilage destruction in load-bearing joints, subchondral sclerosis, osteophyte formation, and some biochemical and morphological changes in the synovial membrane and joint capsule. Common symptoms of knee osteoarthritis are; Knee pain that increases with activity, limitation of normal joint movement of the knee, edema, and knee pain that begins with prolonged sitting. The aim of this study is to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received PRP. **Detailed Description:** OA is a non-inflammatory progressive musculoskeletal disease; damage begins in the cartilage and causes changes in the joint structure over time. Although intra-articular injection approaches have been frequently used in the treatment of OA recently, intra-articular injections known as Platelet Rich Plasma (PRP) have also started to be used frequently. Today, the areas of use of laser therapy have increased. When the laser beam is applied, it is absorbed by the tissue or scattered back. Laser has photochemical, thermal and ionizing effects on tissues. Laser has an analgesic effect by increasing endorphin synthesis and reducing C nerve fiber activation. Laser indirectly increases microcirculation by increasing temperature in the tissue. Although there are various studies on treatment options for OA in the literature, no studies have been found to investigate the effectiveness of laser treatment applied in addition to conventional treatment after PRP. In our study, we aimed to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received PRP. ### Conditions Module **Conditions:** - Knee Osteoarthritis **Keywords:** - Osteoarthritis - Intra-articular injection - PRP (Platelet-rich plasma) - Physiotherapy - Laser Treatment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Within the scope of conventional treatment, individuals were given Transcutaneous Electrical Nerve Stimulation (TENS), infrared, US and exercise therapy. **Intervention Names:** - Other: Laser Treatment **Label:** Conventional treatment **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In the study group, low-dose laser treatment was applied in addition to conventional treatment. Therapeutic Laser device was used for laser treatment. Laser treatment was applied to 8 sensitive points around the knee for 1 minute, for a total of 8 minutes. **Intervention Names:** - Other: Laser Treatment **Label:** Laser treatment **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Conventional treatment - Laser treatment **Description:** In the study group, low-dose laser treatment was applied in addition to conventional treatment. Chattanoga Group Therapeutic Laser device was used for laser treatment. Laser treatment was applied to 8 sensitive points around the knee for 1 minute, for a total of 8 minutes. Laser treatment was applied continuously, with a wavelength of 830nm and a power of 6J. **Name:** Laser Treatment **Other Names:** - conventional treatment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Knee pain severity will measured using the Visual Analog Scale. Scale (VAS). The VAS is a 10 cm scale, where 0 represented no pain and 10 represented unbearable pain. Pain intensity was recorded by measuring the point marked between 0- 10. **Measure:** Pain severity **Time Frame:** Baseline and 2 weeks post-intervention **Description:** WOMAC will be used to evaluate the degree of physical function. This scale has a total of 24 questions and 5 answers between 0-4 for each question. A high score indicates that the symptoms are severe. **Measure:** Function **Time Frame:** 2 weeks post-intervention **Description:** Hip, knee flexor and extensor muscle strengths will be measured using a manual dynamometer. **Measure:** MUSCLE STRENGTH **Time Frame:** Baseline and 2 weeks post-intervention **Description:** Dynamic balance of individuals through the Modified Star Balance Test will be evaluated. **Measure:** BALANCE **Time Frame:** Baseline and 2 weeks post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Volunteering to participate in the study * Being diagnosed with knee OA by a specialist physician * Having had PRP injection applied by a specialist physician * Having unilateral knee OA * Being stage I-stage III in the Kellgren-Lawrence OA classification * Being between the ages of 18-65 Exclusion Criteria: * Being stage IV in the Kellgren-Lawrence OA classification * BMI being more than 40 kg/m2 * Patients who do not cooperate well * Patients with neurological or neuromuscular disease **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sevde Nur AKTAŞ, MsC **Phone:** 05438760764 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Metehan YANA, PhD **Phone:** 05072665522 **Role:** CONTACT #### Locations **Location 1:** **City:** Karabük **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Metehan YANA Phd - **Phone:** 05072665522 - **Role:** CONTACT **Country:** Turkey **Facility:** Karabük University **Status:** RECRUITING **Zip:** 78000 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Fitzgerald GK, Piva SR, Irrgang JJ. Reports of joint instability in knee osteoarthritis: its prevalence and relationship to physical function. Arthritis Rheum. 2004 Dec 15;51(6):941-6. doi: 10.1002/art.20825. **PMID:** 15593258 **Citation:** Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24. **PMID:** 26405113 **Citation:** Hedbom E, Hauselmann HJ. Molecular aspects of pathogenesis in osteoarthritis: the role of inflammation. Cell Mol Life Sci. 2002 Jan;59(1):45-53. doi: 10.1007/s00018-002-8404-z. **PMID:** 11846032 **Citation:** Citaker S, Gunduz AG, Guclu MB, Nazliel B, Irkec C, Kaya D. Relationship between foot sensation and standing balance in patients with multiple sclerosis. Gait Posture. 2011 Jun;34(2):275-8. doi: 10.1016/j.gaitpost.2011.05.015. Epub 2011 Jun 16. **PMID:** 21683600 **Citation:** Chapple CM, Nicholson H, Baxter GD, Abbott JH. Patient characteristics that predict progression of knee osteoarthritis: a systematic review of prognostic studies. Arthritis Care Res (Hoboken). 2011 Aug;63(8):1115-25. doi: 10.1002/acr.20492. **PMID:** 21560257 **Citation:** MILLER JH, WHITE J, NORTON TH. The value of intra-articular injections in osteoarthritis of the knee. J Bone Joint Surg Br. 1958 Nov;40-B(4):636-43. doi: 10.1302/0301-620X.40B4.636. No abstract available. **PMID:** 13610976 **Citation:** McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24. **PMID:** 24462672 **Citation:** Hagiwara S, Iwasaka H, Okuda K, Noguchi T. GaAlAs (830 nm) low-level laser enhances peripheral endogenous opioid analgesia in rats. Lasers Surg Med. 2007 Dec;39(10):797-802. doi: 10.1002/lsm.20583. **PMID:** 18081143 **Citation:** Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015. **PMID:** 25624776 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432829 **Brief Title:** Study on the Effectiveness and Differential Usability of the UP in Spanish University Students **Official Title:** Study on the Efficacy and Differential Usability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Spanish University Students #### Organization Study ID Info **ID:** IPES/PU-E/2024 #### Organization **Class:** OTHER **Full Name:** Instituto de Investigación Sanitaria Aragón ### Status Module #### Completion Date **Date:** 2025-09-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Instituto de Investigación Sanitaria Aragón #### Responsible Party **Investigator Affiliation:** Instituto de Investigación Sanitaria Aragón **Investigator Full Name:** Jorge Javier Osma López **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the Unified Protocol (UP) in its application in two cost-effective formats, the online group and the blended online group for the treatment of emotional disorders in university students in Spain. **Detailed Description:** Introduction: Emotional Disorders (EDs) are the most common disorders among the young population. Despite their high prevalence in university students, data suggest that only 16.4% of students suffering from a mental health disorder receive treatment. Therefore, the present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the Unified Protocol (UP) in its application in two cost-effective formats, the online group and the Blended online group. Method: The study population will be university students who meet diagnostic criteria for EDs. We estimate a sample of 70 students, 35 per condition. The intervention will consist of the application of the 8 modules of the UP in two formats: online group format of 8 weekly sessions of 2 hours duration and Blended format (4 online group sessions, of two hours duration in modules 1,4,6 and 7 of the UP + autonomous work through the UP-APP). The variables evaluated will be collected before the intervention, in the post-treatment and in the follow-ups at one month and 3 months. This study responds to the need to implement services that improve the availability and access to the treatment of EDs in the university context in Spain, and in this particular case, through the formats offered by a transdiagnostic intervention such as the UP. ### Conditions Module **Conditions:** - Emotional Disorder - Depression, Anxiety - Emotion Regulation **Keywords:** - Emotional Disorders - University Students - Unified Protocol - Blended format - Online interventions - Group formats ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be recruited through the Psychological Care Unit (UNAP) of the University of Cordoba (Spain). The UNAP will refer to the research team those persons whose reason for consultation refers to an emotional problem (anxious and/or depressive symptomatology). Potential participants will be contacted by the research team via email and will be sent an information sheet about the study and informed consent, which they will be able to read and sign online through a Google Forms link. ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants are informed of the assigned intervention condition before the start of the intervention **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants assigned to this condition will receive the UP in group format through 8 sessions of 2 hours duration, once a week, in online format through the Google Meet platform. Participants will receive a brief manual with the important contents of each session, the exercises to be performed and the corresponding records. **Intervention Names:** - Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders **Label:** UP in online group format **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants assigned to this condition will receive the PU in a blended group format (4 online group sessions, of two hours duration in modules 1,4,6 and 7 of the PU + autonomous work through the UP-APP). Thus, participants will receive a combined intervention format, working some contents in online group sessions and others through the PU-APP. **Intervention Names:** - Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders **Label:** UP in blended format (UP online group + UP App) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - UP in blended format (UP online group + UP App) - UP in online group format **Description:** This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-group format. For ethical reasons, if any of the patients feel uncomfortable during the study with the online-group format, will may leave the group and receive individual attention. The study plans follow-ups at 1 and 3 months after the end of the treatment. **Name:** Unified Protocol for the transdiagnostic treatment of emotional disorders **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Diagnostic interview to determine if the participant has a clinical diagnosis of emotional disorder (ET) and can be part of the study. The following diagnoses according to the DSM-V are included within the category of emotional disorder: major depressive disorder, dysthymic disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, post-traumatic stress disorder, social anxiety disorder, hypochondria, and adjustment disorders. Patients with anxiety disorders not otherwise specified and those with depressive disorders not otherwise specified will also be included in the study. **Measure:** Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5; Brown & Barlow, 2014) **Time Frame:** Only before of the treatment to check inclusion criteria **Description:** Information will be collected on sex, age, marital status, employment status, type of study (bachelor's degree; postgraduate: master's degree, continuing education courses; doctorate), degree taken and course in which you are enrolled. **Measure:** Questionnaire on Sociodemographic Data (ad hoc) **Time Frame:** Pre-treatment data **Description:** Evaluation through 5 items of the frequency, intensity, severity and interference of depressive symptomatology **Measure:** General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019) **Time Frame:** Up to 3 months follow-up **Description:** Evaluation through 5 items of the frequency, intensity, severity and interference of anxious symptomatology **Measure:** General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019) **Time Frame:** Up to 3 months follow-up **Description:** Evaluation through 49 items of the transdiagnostic profile of Emotional Disorders, which is composed of nine dimensions: neurotic temperament, positive temperament, depressed mood, somatic anxiety, arousal activation, social anxiety, intrusive cognitions, traumatic re-experiencing, and avoidance **Measure:** Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023) **Time Frame:** Up to 3 months follow-up #### Secondary Outcomes **Description:** Evaluation through 28 items of difficulties in emotional regulation by means of 5 subscales: lack of control, rejection, interference, inattention and emotional confusion. **Measure:** Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008) **Time Frame:** Up to 3 months follow-up **Description:** Evaluation of emotional regulation through 10 items, scored on a scale from 1 (strongly disagree) to 7 (strongly agree), with two subscales: cognitive restructuring and emotional suppression. **Measure:** Emotional Regulation Questionnaire (ERQ; Gross & John, 2003. Validated in Spanish by Pineda et al., 2018) **Time Frame:** Up to 3 months follow-up **Description:** Evaluation of the five facets of mindfulness: observing, describing, acting consciously, not judging, internal experience and non-reactivity to internal experience, through 24 items. **Measure:** Short Version of the Five Facets of Mindfulness Questionnaire (FFMQ-SF; Bohlmeijer et al., 2011. Validated in Spanish by Asensio-Martínez et al., 2019) **Time Frame:** Up to 3 months follow-up **Description:** Assessment of self-perceived health status. **Measure:** EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999) **Time Frame:** Up to 3 months follow-up **Description:** Evaluation of the therapeutic alliance through 12 items. **Measure:** Short-format Therapeutic Alliance Inventory (WAI-S; Hatcher and Gillas, 2006. Validated in Spanish by Corbella et al., 2011) **Time Frame:** Up to 3 months follow-up **Description:** Evaluation through 6 items about the extent to which patients' psychological problems affect different areas of daily life: work or studies, social life, free time, couple relationship and family life. **Measure:** Maladjustment Scale (EI; Echeburua; 2000; Validated in Spanish by Quiléz-Orden et al., in press) **Time Frame:** Up to 3 months follow-up **Description:** Our adaptation includes 6 of the 8 items of the CSQ-8 (perceived quality, adequacy to previous expectations, recommendation of the treatment to friends or family, usefulness of the techniques learned, general satisfaction with the intervention and probability that they will choose an intervention of this type again) and one more item related to the discomfort generated by the intervention. Likewise, a change has been made in the Likert response scale from 4 points in the original (0 = "Bad / Not at all" to 4 = "Excellent/Very Much") to 11 in the current one (0 = "Bad / Not at all to 10 = "Excellent/Very Much"). **Measure:** An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979 **Time Frame:** Up to 3 months follow-up **Description:** Questionnaire prepared ad hoc composed of 7 questions; one of a general nature that evaluates the usefulness of the program to improve emotional regulation and six specific ones that separately evaluate the usefulness to better regulate emotions of each of the techniques that are worked on in the different modules of the PU. The response scale is Likert-type and ranges from 0 (not at all) to 10 (very much). **Measure:** Evaluation questionnaire of the PU modules (Ad hoc) **Time Frame:** Up to 3 months follow-up **Description:** Scale used to evaluate the usability of the app included in PU condition in hybrid online group format **Measure:** System Usability Scale (SUS; Brooke, 1996. Validated in Spanish by Sevilla-Gonzalez et al., 2020) **Time Frame:** Up to 3 months follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Be enrolled at the University of Cordoba (Spain), in any of the degrees * Have a diagnosis of anxiety or mood disorder from the Structured Interview for Anxiety and Related Disorders, according to the DSM-5 (ADIS-5)\* * Be at least 18 years old * Be fluent in the Spanish language * Have a technological device (Computer, Tablet, cell phone) with internet connection * Have a smartphone device with Android operating system * In the case of taking pharmacological treatment for the treatment of their ED, maintenance of the same doses and medications for at least 3 months before starting their participation in the study and throughout the treatment * Signature of the informed consent Exclusion Criteria: * Have a diagnosis of Obsessive Compulsive Disorder or Post Traumatic Stress Disorder * Have a severe condition that requires priority for treatment will not be able to participate in the study. This includes a serious mental disorder (personality disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance abuse within the past three months. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jorge Osma, Ph. D. **Phone:** 978645390 **Phone Ext:** 34 **Role:** CONTACT #### Locations **Location 1:** **City:** Teruel **Country:** Spain **Facility:** Instituto de investigación sanitaria de Aragón, universidad de Zaragoza **Zip:** 44003 ### IPD Sharing Statement Module **Description:** Under request **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES ### References Module #### See Also Links **Label:** IPES web (Investigation group) **URL:** https://ipes-group.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: HIGH - As Found: Emotional Disorders - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019964 - Term: Mood Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432816 **Brief Title:** Efficacy of Nano-Pso Therapy in Menopause **Official Title:** Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause #### Organization Study ID Info **ID:** IMI-09-23 #### Organization **Class:** INDUSTRY **Full Name:** Distribuidora Biolife SA de CV ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-28 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Distribuidora Biolife SA de CV #### Responsible Party **Investigator Affiliation:** Distribuidora Biolife SA de CV **Investigator Full Name:** Dra Araceli Espinosa Guerrero **Investigator Title:** DRA. Araceli Espinosa Guerrero **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Vasomotor syndrome is prevalent in 85% of postmenopausal women, hormone therapy in menopause is first-line therapy, but 38% of patients have some contraindication for its use. The medications indicated in this population presents adverse reactions, such as dryness of the mucous membranes, and insomnia in patients, and triggers to abandoned treatment due to poor response to the drug. Aligned with the safety of patients, we wish to test pomegranate seed oil with nanotechnology (NANOPSO), which has been reported to have positive results at a central level, due to its antioxidant effect, which could impact women in climacteric in a positive way. The study involves the participation of 90 patients divided into two groups, where placebo or Nano-PSO will be administered for 60 days, with a total follow-up of 120 days. It is established that patients must not have received previous treatments for menopausal symptoms. Therefore, it is expected that therapy with NANO-PSO compared to placebo will be more effective in controlling vasomotor symptoms in early menopause after 6 months of treatment evaluated by the MRS scale. **Detailed Description:** The menopausal transition in women marks the end of female reproductive capacity and is associated with an estrogenic hormonal imbalance that begins to be noticeable around the fifth decade of life. This process, also known as climacteric, involves the transition from an active to an inactive reproductive stage, and can last for several years before menopause, which is defined as the last menstruation . During the climacteric, the reduction of estrogen triggers clinical signs and symptoms that affect various systems of the body, such as the central nervous system, the cardio-metabolic system, the musculoskeletal system, and sexual function. Vasomotor symptoms, such as hot flashes, are common manifestations at this stage and affect approximately 75-80% of women in the transition to menopause, with an intensity ranging from moderate to severe in most cases. These symptoms can have a negative impact on quality of life, affecting sleep, functional capacity and work attendance . Menopausal hormone therapy (MHT) with estrogens and progesterone is the first line of treatment for vasomotor symptoms in menopause. However, some women cannot or prefer not to use MHT due to its adverse effects, which has led to the development of second-line therapies, such as selective serotonin reuptake inhibitors, gabapentinoids, clonidine, and oxybutynin. These non-hormonal therapies may also have minor side effects that may lead to discontinuation of treatment. In the search for therapeutic alternatives with fewer adverse effects, compounds such as punic acid (omega 5) and its metabolites, such as conjugated linoleic acid, have been investigated. Nanoemulsified pomegranate seed oil (omega 5) has been shown to be a compound with high antioxidant capacity and neuroprotective effects, making it a promising option for the management of symptoms associated with menopause, especially those related to alterations at the level of the menopause. central. Preliminary studies have shown encouraging results in animal models and initial clinical trials, suggesting the need for additional research in specific populations, such as menopausal women. GENERAL OBJECTIVE Compare 6-month NANO-PSO therapy versus placebo in the control of vasomotor symptoms in early menopause, assessed via the Menopause Rating Scale. SPECIFIC OBJECTIVES * Describe the sociodemographic and clinical characteristics of the Study population. * Analyze vasomotor symptoms in menopausal patients at baseline with the MRS scale. * Compare vasomotor symptoms with the use of NANO-PSO vs. Placebo * Compare the percentage of treatment response regarding vasomotor symptoms with the use of nano pso vs placebo at 3 and 6 months. Population study Patients who come first class. outpatient climacteric consultation that presents with early menopause and MRS scale \> 15 points without treatment. With a sample convenience, the aim is to recruit 45 patients per group with a total of 90 patients. Intervention by compounds - Leading to treatment of NANO-PSO or Oil of pomegranate seed with nanotechnology, they are capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast - Placebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO being the following information: Oil edible, oval shape, 640 mg. ### Conditions Module **Conditions:** - Menopause - Vasomotor; Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a multicenter, prospective, analytical and longitudinal study. A sample calculation was made with a therapeutic efficiency of 30% in vasomotor syndrome, with a result of 210 participants, divided into 3 institutions. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** The treatments were received, previously labeled and randomly drawn by the sponsor. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** NANO-PSO or Pomegranate seed oil with nanotechnology, capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast **Intervention Names:** - Dietary Supplement: NANO-PSO **Label:** NANO-PSO **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** - Placebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO being the following information: Oil edible, oval shape, 640 mg. **Intervention Names:** - Other: PLACEBO **Label:** PLACEBO **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - NANO-PSO **Description:** NANO-PSO or Oil of pomegranate seed with nanotechnology, they are capsules with a net content of 640 mg with a dosage indicated by sponsor of 2 capsules in fast **Name:** NANO-PSO **Other Names:** - Oil of pomegranate seed with nanotechnology **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - PLACEBO **Description:** Placebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil 35for PLACEBO Oil edible, oval shape, 640 mg. **Name:** PLACEBO **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** THE MRS IS A SCALE TO IDENTIFY THE FREQUENCY AND INTENSITY OF MENOPAUSE SYMPTOMS **Measure:** MENOPAUSE RATING SCALE **Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS. **Description:** Follicle-stimulating hormone (FSH) is a pituitary hormone that regulates the reproductive cycle, helps control the menstrual cycle and the production of eggs in the ovaries. **Measure:** FSH HORMONE **Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS. **Description:** The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire commonly used to evaluate sleep quality in adults. Created by the Department of Psychiatry at the University of Pittsburgh in 1988, the PSQI addresses both qualitative and quantitative aspects of sleep experienced during the month prior to its administration. **Measure:** PITTSBURG SCALE **Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS. **Description:** The STRAW+10 system is a clinical and objective way to stage patients transitioning to menopause. **Measure:** STRAW+10 **Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS. #### Secondary Outcomes **Description:** The PHQ-9 is a nine-item self-report measure that assesses the presence of depressive symptoms based on DSM-IV criteria. **Measure:** PHQ-9 **Time Frame:** 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS. **Description:** Estradiol is a female sex hormone that regulates many processes in the body in the reproductive age, its evaluation will only be a control. **Measure:** ESTRADIOL **Time Frame:** EVALUATION WILL BE CARRIED OUT AFTER SIX MONTHS. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * In perimenopause with vasomotor syndrome and score greater than 15 points staged with the MRS scale * They agree to participate and sign the consent informed. * Without prior treatment to relieve the symptoms of menopause. Exclusion Criteria: * - With pharmacological and/or hormonal therapy prescribed for menopause symptoms. * With psychiatric pathologies such as anxiety and depression. * Hysterectomized patients or patients with induced menopause surgically early. * Smoking * Malnutrition or low weight determined by a BMI ≤ 18.5Kg/m2 Elimination criteria. * Who do not attend follow-up to provide their treatment the 1, 2, 3 and 4 months for application of the MRS scale * That they leave the study voluntarily. * Who present any serious adverse effect to the drug. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 45 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ARACELI ESPINOSA GUERREO, DRA. **Phone:** 527228228390 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Liliana D Esparragosa Salazar, MC **Phone:** 527221486139 **Role:** CONTACT #### Locations **Location 1:** **City:** Toluca **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** LILIANA D ESPARRAGOZA SALAZAR, PH - **Phone:** 527221486139 - **Role:** CONTACT ***Contact 2:*** - **Name:** ARACELI ESPINOSA GUERRERO, PH - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Mexico **Facility:** Maternal and Child Institute of the State of Mexico **State:** State OF Mexico **Status:** RECRUITING **Zip:** 50170 #### Overall Officials **Official 1:** **Affiliation:** Maternal and child institute of the State of Mexico **Name:** ARACELI ESPINOSA GUERREO **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** El Khoudary SR, McClure CK, VoPham T, Karvonen-Gutierrez CA, Sternfeld B, Cauley JA, Khalil N, Sutton-Tyrrell K. Longitudinal assessment of the menopausal transition, endogenous sex hormones, and perception of physical functioning: the Study of Women's Health Across the Nation. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):1011-7. doi: 10.1093/gerona/glt285. Epub 2014 Jan 24. **PMID:** 24465026 **Citation:** Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2. **PMID:** 29393299 **Citation:** Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 Dec;45(4):629-640. doi: 10.1016/j.ogc.2018.07.005. Epub 2018 Oct 25. **PMID:** 30401547 **Citation:** Kim MJ, Yim G, Park HY. Vasomotor and physical menopausal symptoms are associated with sleep quality. PLoS One. 2018 Feb 20;13(2):e0192934. doi: 10.1371/journal.pone.0192934. eCollection 2018. **PMID:** 29462162 **Citation:** Petrou P, Ginzberg A, Binyamin O, Karussis D. Beneficial effects of a nano formulation of pomegranate seed oil, GranaGard, on the cognitive function of multiple sclerosis patients. Mult Scler Relat Disord. 2021 Sep;54:103103. doi: 10.1016/j.msard.2021.103103. Epub 2021 Jun 27. **PMID:** 34243101 **Citation:** Auerbach L, Rakus J, Bauer C, Gerner C, Ullmann R, Wimmer H, Huber J. Pomegranate seed oil in women with menopausal symptoms: a prospective randomized, placebo-controlled, double-blinded trial. Menopause. 2012 Apr;19(4):426-32. doi: 10.1097/gme.0b013e3182345b2f. **PMID:** 22240636 **Citation:** Mori-Okamoto J, Otawara-Hamamoto Y, Yamato H, Yoshimura H. Pomegranate extract improves a depressive state and bone properties in menopausal syndrome model ovariectomized mice. J Ethnopharmacol. 2004 May;92(1):93-101. doi: 10.1016/j.jep.2004.02.006. **PMID:** 15099854 **Citation:** Valdes-Sustaita B, Estrada-Camarena E, Gonzalez-Trujano ME, Lopez-Rubalcava C. Estrogen receptors-beta and serotonin mediate the antidepressant-like effect of an aqueous extract of pomegranate in ovariectomized rats. Neurochem Int. 2021 Jan;142:104904. doi: 10.1016/j.neuint.2020.104904. Epub 2020 Nov 18. **PMID:** 33220387 **Citation:** Adel-Mehraban MS, Tansaz M, Mohammadi M, Yavari M. Effects of pomegranate supplement on menopausal symptoms and quality of life in menopausal women: A double-blind randomized placebo-controlled trial. Complement Ther Clin Pract. 2022 Feb;46:101544. doi: 10.1016/j.ctcp.2022.101544. Epub 2022 Feb 2. **PMID:** 35134697 **Citation:** Kim JH, Kim YJ, Park Y. Conjugated Linoleic Acid and Postmenopausal Women's Health. J Food Sci. 2015 Jun;80(6):R1137-43. doi: 10.1111/1750-3841.12905. Epub 2015 May 11. **PMID:** 25962640 **Citation:** Posadzki P, Lee MS, Moon TW, Choi TY, Park TY, Ernst E. Prevalence of complementary and alternative medicine (CAM) use by menopausal women: a systematic review of surveys. Maturitas. 2013 May;75(1):34-43. doi: 10.1016/j.maturitas.2013.02.005. Epub 2013 Mar 14. **PMID:** 23497959 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M19020 - Name: Primary Ovarian Insufficiency - Relevance: LOW - As Found: Unknown - ID: M11577 - Name: Menopause, Premature - Relevance: LOW - As Found: Unknown - ID: T6036 - Name: Menopause - Relevance: HIGH - As Found: Menopause ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T257 - Name: Pomegranate - Relevance: HIGH - As Found: Grade 3 follicular lymphoma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432803 **Acronym:** MIDAS **Brief Title:** Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS **Official Title:** Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS #### Organization Study ID Info **ID:** 69HCL24_0511 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospices Civils de Lyon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Autoimmune encephalitis (AE) is a rare neurological disorder mediated by autoimmune antibody response against neuronal cell surface and intraneuronal proteins associated with specific brain areas, resulting in severe inflammation and damage in the associated brain regions, all most frequently manifesting diverse cognition and memory impairment symptoms at follow-up. However, these symptoms may co-exist or mimic other CNS autoimmune and neurodegenerative disorders. The most common guideline for diagnosing autoimmune encephalitis relies on cerebrospinal fluid (CSF) antibody testing which might take several weeks to obtain, making it not optimal for the early diagnosis of AE. As for magnetic resonance imaging (MRI), which is the most common imaging tool utilized for aiding in the diagnosis of AE, can possess several limitations as some patients, like anti-NMDAr AE patients, can present memory and behavioral deficits even in the presence of normal brain MRI. Positron emission tomography (PET) with 2-deoxy-2-\[fluorine-18\] fluoro-D-glucose (18F-FDG) have been addressed by several studies as an important examination for the early diagnosis of AE . One study demonstrated that the fraction of having an abnormal MRI in AE patients is lower than having an abnormal PET, by which certain PET patterns were associated with autoantibody types of AE. Moreover, one report demonstrated that even with autoantibody negative test and normal brain MRI, FDG-PET examination showed abnormal hypometabolism and hypermetabolism patterns. More specifically, these distinct patterns include medial temporal and striatal hypermetabolism with cortical diffuse hypometabolism. Leiris et al. revealed that the methadology used for the analysis of these PET images is highly variable, especially intensity normalization methods, where most possess some limitations (e.g., proportional scaling) as they can impede the accurate differential diagnosis of autoimmune encephalitis (AE) by potentially indicating false hypermetabolism in otherwise preserved brain regions. Absolute quantification is not possible since the disease presents both diffuse hypometabolism and hypermetabolism on PET images. So, they suggested that it's best to parametrize the brain's activity by dividing it by that of the striatum. Their voxel-based analysis, comparing individuals with AE to both healthy subjects and those with mild cognitive impairment (MCI), demonstrated that a decrease in the cortex/striatal metabolic ratio is a robust biomarker for the early diagnosis of AE. ### Conditions Module **Conditions:** - Paraneoplastic Neurological Syndrome - Autoimmune Encephalitis **Keywords:** - Paraneoplastic neurological disorders - autoimmune encephalitis - auto-antibodies - PET-SCAN ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 28 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Analysis of PET-scan **Intervention Names:** - Other: PET-Scan analysis **Label:** Auto-immune encephalitis patients #### Arm Group 2 **Description:** Analysis of PET-scan **Intervention Names:** - Other: PET-Scan analysis **Label:** Paraneoplastic Neurological Syndromes patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Auto-immune encephalitis patients - Paraneoplastic Neurological Syndromes patients **Description:** Investigate and determine the clinical value of different cortex/striatal metabolic ratio patterns in each antibody-specific subtype of autoimmune encephalitis **Name:** PET-Scan analysis **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Decrease in the metabolic ratio cortex/striatum in included patients, compared to a control reference cohort. **Measure:** Ratio metabolic cortex-striatum **Time Frame:** Up to 10 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patient with positivity of auto-antibody in CSF * patient \>18 years old * patient with auto-immune encephalitis or paraneoplastic neurological syndrome Exclusion Criteria: - patient without data **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients will be included from the from the database of the French Reference Centre for Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis (Lyon, France) ### Contacts Locations Module #### Locations **Location 1:** **City:** Pierre-Bénite **Country:** France **Facility:** CHU Lyon **Zip:** 69495 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000090862 - Term: Neuroinflammatory Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000013967 - Term: Thyroiditis, Autoimmune - ID: D000013966 - Term: Thyroiditis - ID: D000013959 - Term: Thyroid Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M7825 - Name: Encephalitis - Relevance: HIGH - As Found: Encephalitis - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: HIGH - As Found: Autoimmune Encephalitis - ID: M26156 - Name: Hashimoto Disease - Relevance: HIGH - As Found: Autoimmune Encephalitis - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M2803 - Name: Neuroinflammatory Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M16725 - Name: Thyroiditis - Relevance: LOW - As Found: Unknown - ID: M16726 - Name: Thyroiditis, Autoimmune - Relevance: LOW - As Found: Unknown - ID: M16718 - Name: Thyroid Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T554 - Name: Autoimmune Encephalitis - Relevance: HIGH - As Found: Autoimmune Encephalitis - ID: T2673 - Name: Hashimoto Encephalopathy - Relevance: HIGH - As Found: Autoimmune Encephalitis - ID: T3542 - Name: Lymphomatous Thyroiditis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004660 - Term: Encephalitis - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000050031 - Term: Hashimoto Disease ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4625 - Name: Autoantibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432790 **Acronym:** CHAMPION **Brief Title:** Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline **Official Title:** Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION) #### Organization Study ID Info **ID:** 2022A018209 #### Organization **Class:** OTHER **Full Name:** Massachusetts General Hospital #### Secondary ID Infos **Domain:** Patient-Centered Outcomes Research Institute (PCORI) **ID:** TE-2022C3-30362 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2028-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** American Academy of Pediatrics #### Lead Sponsor **Class:** OTHER **Name:** Massachusetts General Hospital #### Responsible Party **Investigator Affiliation:** Massachusetts General Hospital **Investigator Full Name:** Lauren G. Fiechtner, M.D. **Investigator Title:** Assistant Professor of Pediatrics **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to evaluate the effectiveness of CHAMPION, a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. Intensive Health Behavior and Lifestyle Treatment (IHBLT), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma. **Detailed Description:** This study will evaluate the comparative effectiveness of 1) telehealth delivery of CHAMPION vs. 2) in-person (standard of care) delivery of CHAMPION in a two-arm, individually randomized non-inferiority trial among 500 children. Obesity and asthma are two leading chronic diseases in children, and CHAMPION is an integration of the Healthy Weight Clinic (HWC) and pediatric Asthma Population Health Management Programming at Mass General Brigham. This study will address how to improve access to effective treatments consistent with United States Preventive Services Task Force and American Academy of Pediatrics guidelines that manage asthma and obesity concurrently in primary care among lower income diverse populations ### Conditions Module **Conditions:** - Overweight, Childhood - Obesity, Childhood - Asthma in Children **Keywords:** - telehealth ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** * Intensive 0-6 months: 1 individual visit monthly (virtual), 1 group visit monthly (virtual) * Maintenance 6-12 months: 1 individual visit monthly (virtual), 2 health coaching calls per month **Intervention Names:** - Behavioral: CHAMPION **Label:** CHAMPION via Telehealth **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** * Intensive 0-6 months: 1 individual visit monthly (in-person), 1 group visit monthly (in-person) * Maintenance 6-12 months: 1 individual visit monthly (in-person), 2 health coaching calls per month **Intervention Names:** - Behavioral: CHAMPION **Label:** CHAMPION In-Person **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - CHAMPION In-Person - CHAMPION via Telehealth **Description:** The CHAMPION program is an intensive health behavior and lifestyle treatment (IHBLT), formed through the integration of the Healthy Weight Clinic IHBLT and with MGB's pediatric Asthma Population Health Management Program. It consists of 30 hours of contact time with the CHAMPION team (physician, dietician, community health worker), consistent with the USPSTF and AAP recommendations, monthly individual clinic visits with the team (in person or virtual, per randomization), health coaching calls with a community health worker and/or registered dietician, monthly group sessions (in the first six months), and educational materials for families that reinforce healthy lifestyle behaviors and provide self-management education. **Name:** CHAMPION **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Measured as BMI based on child height and weight **Measure:** Change in Child BMI **Time Frame:** 0-12 months **Description:** Measured as BMI based on child height and weight, and derived from CDC growth curves accounting for child age and sex **Measure:** Change in Child BMI z-score **Time Frame:** 0-12 months **Description:** Per Asthma Control Test **Measure:** Change in Asthma Control Test **Time Frame:** 0-12 months **Description:** Per response to caregiver-proxy survey **Measure:** Change in Asthma and Obesity Specific Quality of Life **Time Frame:** 0-12 months #### Secondary Outcomes **Description:** Diet quality per Primescreen, via caregiver-proxy survey **Measure:** Change in Child Diet Quality **Time Frame:** 0-12 months **Description:** Hours of sleep, via caregiver-proxy survey **Measure:** Change in Child Average Hours of Sleep **Time Frame:** 0-12 months **Description:** Days physically active for at least 60 minutes per day, via caregiver-proxy survey **Measure:** Change in Child Average Days of Physical Activity **Time Frame:** 0-12 months **Description:** Hours of sedentary screen time, via caregiver-proxy survey **Measure:** Change in Child Average Hours of Screen Time **Time Frame:** 0-12 months **Description:** Per response to caregiver-proxy survey **Measure:** Asthma-related healthcare utilization **Time Frame:** 0-12 months **Description:** Per response to caregiver-proxy survey **Measure:** Change in perceived stress (caregiver) **Time Frame:** 0-12 months **Description:** Per response to caregiver-proxy survey **Measure:** Family-centered care assessment **Time Frame:** 12 months **Description:** Per response to caregiver-proxy survey **Measure:** Telehealth satisfaction **Time Frame:** 12 months **Description:** Per response to caregiver-proxy survey **Measure:** Barriers to program attendance **Time Frame:** 12 months **Description:** Per response to caregiver-proxy survey **Measure:** Change in disordered eating symptoms **Time Frame:** 0-12 months ### Eligibility Module **Eligibility Criteria:** Caregiver-proxies will be 18 years old or older, English or Spanish speaking, and a primary caregiver of a child meeting the following criteria: Inclusion criteria * Age 6-17.9 years at time of screening * BMI ≥ 85th percentile * Asthma diagnosis, per child's EHR documentation or caregiver report Exclusion criteria * Diagnosis of anorexia nervosa, per child's EHR or caregiver report * Pregnant, per child's EHR * Plan to change pediatricians in the next year, per caregiver report * Opted out of research, per child's EHR * Sibling currently enrolled in the research trial, per enrollment log or caregiver report **Maximum Age:** 17 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lauren Fiechtner, MD **Phone:** 617-726-8705 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sheila Kelly, MPH **Role:** CONTACT ### IPD Sharing Statement Module **Description:** The funder, PCORI, requires data to be deposited into the Patient Centered Outcomes Data Repository/University of Michigan ICPSR. **Info Types:** - STUDY_PROTOCOL - ICF - CSR **IPD Sharing:** YES **Time Frame:** Data will be deposited after study completion. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight - ID: D000009765 - Term: Obesity ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M26186 - Name: Overweight - Relevance: HIGH - As Found: Overweight - ID: M30155 - Name: Pediatric Obesity - Relevance: HIGH - As Found: Overweight, Childhood - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma - ID: D000050177 - Term: Overweight - ID: D000063766 - Term: Pediatric Obesity ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432777 **Acronym:** CABARET **Brief Title:** Recurrent Campylobacter Bacteraemia in Immunocompromised Patients **Official Title:** Recurrent Campylobacter Bacteraemia in Immunocompromised Patients: a Retrospective Nationwide Study in France, 2000-2025 #### Organization Study ID Info **ID:** 69HCL24_0512 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospices Civils de Lyon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Some rare cases of recurrent Campylobacter bacteraemia (RCB) exist with relapses months to years after an effective treatment and a negativation of all bacterial samples. As of today, only around 20 cases have been described in the international literature for the last 30 years. The cases are likely highly underreported. No study describes those recurrent Campylobacter bacteraemias at the scale of a country. The aim of this multicentre, nationwide, retrospective study is to describe their precise epidemiology in France for the last 25 years, the immune profile of the patients, the specificities of the bacteria involved, the treatments received and the evolution of these infections. The perspective is to propose a standardization of the medical care of those patients mainly by describing the effective treatments and the explorations of the immune system which should be considered. ### Conditions Module **Conditions:** - Campylobacter Infections **Keywords:** - primary immunodeficiency - Campylobacter - Relapsing bacteraemia ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients presenting at least two distinct episodes of Campylobacter bacteraemia separated by minimum 60 days and an immunodeficiency (innate or acquired) and followed by a French hospital **Intervention Names:** - Other: Characteristics of patients and Campylobacter bacteraemia episodes **Label:** Recurrent Campylobacter bacteraemia ### Interventions #### Intervention 1 **Arm Group Labels:** - Recurrent Campylobacter bacteraemia **Description:** Variables: characteristics of the patients (demographic characteristics; characteristics of immunodeficiency: diagnosis, immunoglobulin dosage, white cells count etc.; chronic inflammatory bowel disease \[IBD\]), the bacteria (species, antimicrobial susceptibility) and the infection (clinical presentation, evolution, treatment received) **Name:** Characteristics of patients and Campylobacter bacteraemia episodes **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** -demographic characteristics **Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia **Time Frame:** Baseline **Description:** -characteristics of immunodeficiency: diagnosis, immunoglobulin dosage, white cells count, polyvalent Ig replacement therapy **Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia **Time Frame:** Baseline **Description:** -chronic inflammatory bowel disease \[IBD\] **Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia **Time Frame:** Baseline **Description:** -characteristics of bacteraemia: clinical presentation, bacteria (species, antimicrobial susceptibility), secondary localizations, evolution, treatment modalities (antibiotics and immunother **Measure:** Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 2 episodes or more of Campylobacter bacteraemia separated by at least 60 days * AND immunodeficiency condition * followed by a French hospital Exclusion Criteria: -Opposition of the patient **Maximum Age:** 100 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** French hospitals ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Anne CONRAD, Dr **Phone:** +33 (0)4 72 07 11 07 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nicolas BENECH, Dr **Role:** CONTACT #### Locations **Location 1:** **City:** Lyon **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Anne CONRAD, MD-PhD - **Phone:** +33472071107 - **Role:** CONTACT **Country:** France **Facility:** Infectious diseases department, Hospital de la Croix Rousse, **Zip:** 69004 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000018805 - Term: Sepsis - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes - ID: D000016905 - Term: Gram-Negative Bacterial Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M18877 - Name: Bacteremia - Relevance: HIGH - As Found: Bacteremia - ID: M5429 - Name: Campylobacter Infections - Relevance: HIGH - As Found: Campylobacter Infections - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: LOW - As Found: Unknown - ID: M2285 - Name: Primary Immunodeficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M19249 - Name: Gram-Negative Bacterial Infections - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016470 - Term: Bacteremia - ID: D000002169 - Term: Campylobacter Infections ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432764 **Brief Title:** Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease. **Official Title:** A Phase Ib Open Label Positron Emission Tomography Study to Assess Changes in Intestinal [11C]AZ14132516 Uptake Following Administration of Multiple Doses of AZD7798 to Patients With Crohn's Disease. #### Organization Study ID Info **ID:** D9690C00007 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca #### Secondary ID Infos **Domain:** CTIS **ID:** 2024-512992-11-00 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2026-02-13 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-02-13 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to measure the changes in intestinal uptake of radioligand \[11C\]AZ14132516 following multiple doses of AZD7798 in participants with Crohn's disease. ### Conditions Module **Conditions:** - Crohn Disease ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Masking Description:** Open label study **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Arm consists of up to 2 panels **Intervention Names:** - Drug: AZD7798 - Drug: [11C]AZ14132516 **Label:** AZD7798 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - AZD7798 **Description:** Each participating patient will receive the study drug as specified in the study protocol. **Name:** AZD7798 **Other Names:** - Study Drug **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - AZD7798 **Description:** A single microdose (≤ 10 μg) of radiopharmaceutical \[11C\]AZ14132516 will be extemporaneously prepared and administered to each participant prior to each PET examination **Name:** [11C]AZ14132516 **Other Names:** - Radioligand **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Safety will be assessed by Adverse Events, vital signs, haematology and clinical chemistry **Measure:** Number of participants with safety findings, AEs **Time Frame:** Until final follow-up, week 24 (may vary between participants) #### Primary Outcomes **Description:** Standardized uptake value (SUV) is the radioactivity concentration in given region of interest normalized for injected radioactivity and body weight. Standardised uptake value ratio (SUVR) is the ratio of SUV in a given region of interest to a reference region without significant radioligand uptake **Measure:** Change from baseline in intestinal SUV/SUVR **Time Frame:** Weeks 13, 16, 20 and 24 (may vary between participants) #### Secondary Outcomes **Measure:** Serum AZD7798 concentration **Time Frame:** Weeks 0, 4, 8, 12 (may vary between participants) **Measure:** Incidence and titre of anti-drug antibodies **Time Frame:** Week 0, 4, 8, 12 and 24 (may vary between participants) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant must be ≥ 20 to 80 years of age, inclusive, at the time of signing the informed consent. * Participants with confirmed Crohn's disease with small bowel involvement (Montreal terminal ileum \[L1\] or ileocolon \[L3\]) per study gastroenterologist (diagnosed via combination of clinical findings and at least one of endoscopy and/or histology and/or imaging) with diagnosis made at least 6 months before screening. * Participants with active Crohn's disease as determined by one of the following: 1. Evidence of active inflammation on cross-sectional imaging (CT, MRI or bowel ultrasound scan) or endoscopy within 6 months before screening OR EITHER 2. If no cross-sectional imaging or endoscopy performed within 6 months before screening, a bowel ultrasound scan may be performed to confirm active disease OR 3. If no cross-sectional imaging or endoscopy performed within 6 months before screening, elevated faecal calprotectin AND CRP * Body habitus compatible with PET examination. * Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent * Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures. Exclusion Criteria: * Other form of IBD or concomitant, additional, active GI luminal inflammatory diseases. * CMV colitis within 12 months before screening. * Crohn's complications including short bowel syndrome, strictures that are symptomatic or with pre-stenotic dilatation or other conditions where surgery anticipated during study period. * Planned bowel or perianal surgery within 6 months before screening. * Bowel resection surgery within 6 months before screening. * Undrained fistula or abscess (including active perianal disease). * Positive Clostridium difficile toxin test during screening. * Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, GI disease, or other major diseases other than active Crohn's disease and associated extra-intestinal manifestations. * Ongoing psychiatric conditions that in the opinion of the Investigator, precludes study participation. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to biologic therapies. * Participants with unstable hypertension (as judged by the Investigator) or symptomatic hypotension, history of pre-syncope or syncope due to orthostatic hypotension and/or induced by change of posture. * Significant abnormalities on clinical examination, including neurological and physical examination, vital signs, and ECG, other than signs of Crohn's disease. * Clinical chemistry, haematology, or urine analysis results that may interfere with the study or present a safety risk to the participant. * Abnormal vital signs, after 10 minutes of supine rest as judged by the Investigator. * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG that may interfere with the interpretation of QTc changes. * Positive hepatitis B, hepatitis C, or HIV serology * Treatment with an anti-TNF within 8 weeks of the first dose and throughout the study period, before the first dose and throughout study period, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable. * Treatment with any biologic, other than an anti-TNF (including vedolizumab and ustekinumab) within 12 weeks prior to first dose and throughout the study period, unless therapeutic drug monitoring is performed, and drug concentrations are undetectable. * Treatment with rituximab within 12 months before first dose and throughout the study period. * Treatment with Sphigosine-1-phosphate receptor modulators or Janus kinase inhibitors within 4 weeks before first dose and throughout the study period. * Treatment with apheresis (eg, Adacolumn, Cellsorba) within 2 weeks prior to first dose and throughout the study period. * Treatment with corticosteroids at a total daily dose of greater than 20 mg prednisone or equivalent (greater than 9 mg budesonide). * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or site staff). * Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. * Suffers from claustrophobia that limits the ability to undergo the scanning procedure. * Positive SARS-CoV-2 rapid antigen test at screening. * Any other reason that, in the study Investigator opinion, prohibits the inclusion of the participants into the study. * Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. * Live or attenuated vaccine within 4 weeks before screening and until 12 weeks after the end of the follow-up period (1 year for Bacillus Calmette-Guérin vaccination). * An active infection, or history of serious infection within 28 days before screening. * History of symptomatic herpes simplex (excluding cold sores) or herpes zoster infection within 3 months prior to screening. * Positive or indeterminate TB QuantiFERON test performed within 1 year of screening (without known interval exposure to TB) or during screening period unless evidence of completion of full treatment course for latent TB with no clinical symptoms or signs indicative of re activation. * Chest x-ray with signs of malignancy or latent or active TB infection performed within 1 year of screening (without known interval exposure to TB) or during screening period. * Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days/5 half-lives, whichever is longer, of the first administration of IMP in this study. The period of exclusion begins 30 days/5 half-lives after the final dose, whichever is longer, . * Current malignancy or history of malignancy, except for: 1. Basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to screening. 2. Other non-GI malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years before screening. * For females only: Currently pregnant (confirmed with positive pregnancy test) or breastfeeding. **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Stockholm **Country:** Sweden **Facility:** Karolinska University Hospital Huddinge **Zip:** 141 86 #### Overall Officials **Official 1:** **Affiliation:** Karolinska University Hospital **Name:** Maria Creignou **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015212 - Term: Inflammatory Bowel Diseases - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6638 - Name: Crohn Disease - Relevance: HIGH - As Found: Crohn's Disease - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003424 - Term: Crohn Disease ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21258 - Name: Radiopharmaceuticals - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432751 **Acronym:** SGLT2i-PO-AKI **Brief Title:** Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery **Official Title:** Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery #### Organization Study ID Info **ID:** 69HCL24_0517 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2024-05-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-10 **Type:** ACTUAL #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospices Civils de Lyon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cardiac surgery with cardiopulmonary bypass exposes patients to the risk of post-operative acute kidney injury. In the specific setting of cardiac surgery, acute kidney injury is often of multifactorial origindue to particular haemodynamic mechanisms, renal hypoxia, or damage linked in the inflammatory reaction or haemolysis. In recent years, inhibitors of the sodium/glucose co-transporter type 2 have demonstrated their relevance in reducing the morbidity and mortality associated with chronic or acute heart failure and chronic kidney disease. These drugs were initially developed to optimise glycaemic control in diabetic patients. They are currently recommended as part of the management of diabetic patients at high cardiovascular risk, patients with systolic and/or diastolic heart failure, and patients with chronic kidney disease. Some pharmacodynamic properties of SGLT2i suggest that they could have a beneficial effect in preventing the onset of acute kidney injury, but also that they could lead to potentially deleterious effects in renal haemodynamic in specific situations. The aim of the study was to estimate the impact of pre-operative exposure to SGLT2i on the occurrence of post-operative acute kidney injury in high-risk renal patients undergoing cardiac surgery. ### Conditions Module **Conditions:** - Acute Kidney Injury - Cardiac Surgery - Sodium/Glucose Cotransporter Inhibitor 2 **Keywords:** - Acute Kidney Injury ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adults patients with pre-operative simplified predictive risk index for renal replacement therapy after cardiac surgery ≥2, with cardiac surgery performed in Louis Pradel Hospital between 08/2022 and 02/2024. **Intervention Names:** - Other: Post Operative Acute Kidney Injury **Label:** Cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort **Description:** Serum creatinine increase by 0.3 mg/dl within 48 h OR Serum creatinine ≥ 1.5-1.9 times baseline within 7 days Baseline creatinine is defined as the last pre-operative value available in the medical file **Name:** Post Operative Acute Kidney Injury **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Serum creatinine increase by 0.3 mg/dl within 48 h **Measure:** Post-operative acute kidney injury **Time Frame:** Baseline creatinine is defined as the last pre-operative value available in the medical file Variation of the creatinine was explored in the first 7 postoperative days **Description:** Serum creatinine ≥ 1.5-1.9 times baseline within 7 days **Measure:** Post-operative acute kidney injury **Time Frame:** Baseline creatinine is defined as the last pre-operative value available in the medical file Variation of the creatinine was explored in the first 7 postoperative days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years * Cardiac surgery with cardiopulmonary bypass * Presenting a simplified renal risk score ≥ 2 points defined as follows: * Pre-operative glomerular filtration rate (≤ 60; ≤ 30 mL/min/1.73m2): 1-2 points * Diabetes requiring treatment: 1 point * LVEF ≤ 40%: 1 point * Previous cardiac surgery: 1 point * Pre-operative intra-aortic counter pulsation: 1 point * Non elective surgery: 1 point * Surgery other than closure of an atrial septal defect or coronary bypass surgery: 1 point Exclusion Criteria: * Haemodialysis prior to surgery * Acute kidney injury prior to surgery as defined in the primary endpoint. If this criterion is not available, patients will only be included if glomerular filtration rate estimated by the CKD-EPI formula is ≥75 mL/min/1.73m2. * Death in the operating theatre * Opposition of the patient to the use of his/her health data **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 1200 patients admitted in the Louis Pradel Hospital for cardiac surgery in the study period ### Contacts Locations Module #### Locations **Location 1:** **City:** Bron **Country:** France **Facility:** Hôpital cardiologique Louis Pradel Groupe Hospitalier Est **State:** Rhône **Zip:** 69500 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M26718 - Name: Renal Insufficiency - Relevance: HIGH - As Found: Renal Failure - ID: M28998 - Name: Acute Kidney Injury - Relevance: HIGH - As Found: Acute Kidney Injury - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000058186 - Term: Acute Kidney Injury - ID: D000051437 - Term: Renal Insufficiency ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432738 **Brief Title:** ZL-82 Double-blind Clinical Trial **Official Title:** A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Design to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and QTc Effect Research #### Organization Study ID Info **ID:** ZL82-H-Ib #### Organization **Class:** INDUSTRY **Full Name:** Chengdu Zenitar Biomedical Technology Co., Ltd ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-03-24 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chengdu Zenitar Biomedical Technology Co., Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** ZL-82 tablets are highly selective covalent irreversible inhibitors of non-receptor tyrosine protein kinase 3 (Janus kinase 3, JAK3) developed by Chengdu Xiuling Biomedical Technology Co., Ltd. According to Document No. 44 of 2020 "Chemical Drug Registration Classification and Application Document Requirements", it belongs to Category 1 chemical drugs and is an innovative drug that has not been marketed at home or abroad. ZL-82 tablets have completed non-clinical pharmacology, non-clinical PK, and toxicology experiments, and have obtained the first-in-human randomized double-blind, placebo-controlled, dose-increasing dose-increasing approval for single oral administration of ZL-82 tablets. Partial results of the phase I clinical study on safety tolerability, pharmacokinetics and preliminary pharmacodynamics. It is necessary to further explore the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of multiple administrations based on the results obtained from the first human trial. Non-clinical in vitro hERG tests and in vivo animal safety pharmacology tests of ZL-82 tablets showed no relevant cardiac safety concerns. According to the ICH E14 guideline "Clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects of Non-Antiarrhythmic Drugs" Evaluation》2, it is recommended to conduct cardiac safety evaluation of experimental drugs with systemic bioavailability to evaluate the impact of experimental drugs on cardiac safety. This evaluation should include evaluation of the effect of the new drug on the QT/QTc interval and collection of adverse cardiovascular events. Establishing a relationship between ZL-82 drug concentration and QT/QTc interval changes will provide additional information for the analysis of cardiac repolarization trial planning and interpretation to facilitate analysis of the effects of drugs on QT/QTc interval changes. Concentration-response analysis, used to characterize the effect of the test drug on the QT/QTc interval, can be used as an alternative to time point analysis. This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of ZL-82 tablets in single/multiple oral doses in healthy subjects, and will also evaluate the effect of ZL-82 tablets on QTc. ### Conditions Module **Conditions:** - Healthy Person ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The subjects in the single-dose group were fasted and water-free for at least 10 hours the night before the administration. On the first day of the study (D1), the subjects were given ZL-82 tablets or placebo according to the requirements of the random table, and were followed as per the study. Schedule safety inspections and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; complete a series of safety inspections, PK, and PD sample collection on the 3rd day and leave the clinical trial facility on the 7th day Safety follow-up. **Intervention Names:** - Drug: ZL-82 **Label:** 600mg ZL-82 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The subjects in the single-dose group were fasted and water-free for at least 10 hours the night before the administration. On the first day of the study (D1), the subjects were given ZL-82 tablets or placebo according to the requirements of the random table, and were followed as per the study. Schedule safety inspections and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; complete a series of safety inspections, PK, and PD sample collection on the 3rd day and leave the clinical trial facility on the 7th day Safety follow-up. **Intervention Names:** - Drug: ZL-82 placebo **Label:** 600mg ZL-82 placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. **Intervention Names:** - Drug: ZL-82 **Label:** 50mg ZL-82 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. **Intervention Names:** - Drug: ZL-82 placebo **Label:** 50mg ZL-82 placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. **Intervention Names:** - Drug: ZL-82 **Label:** 100mg ZL-82 **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. **Intervention Names:** - Drug: ZL-82 placebo **Label:** 100mg ZL-82 placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 7 **Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. **Intervention Names:** - Drug: ZL-82 **Label:** 200mg ZL-82 **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. **Intervention Names:** - Drug: ZL-82 placebo **Label:** 200mg ZL-82 placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 100mg ZL-82 - 200mg ZL-82 - 50mg ZL-82 - 600mg ZL-82 **Description:** This group of subjects take ZL-82 **Name:** ZL-82 **Other Names:** - 600mg ZL-82 - 50mg ZL-82 - 100mg ZL-82 - 200mg ZL-82 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 100mg ZL-82 placebo - 200mg ZL-82 placebo - 50mg ZL-82 placebo - 600mg ZL-82 placebo **Description:** This group of subjects take ZL-82 placebo **Name:** ZL-82 placebo **Other Names:** - 600mg ZL-82 placebo - 50mg ZL-82 placebo - 100mg ZL-82 placebo - 200mg ZL-82 placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** security indicators **Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：Cmax **Time Frame:** 72hours **Description:** Estimation of time to reach Cmax **Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：Tmax **Time Frame:** 72hours **Description:** Estimation of AUC from time zero to the last measured time point **Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：AUC0-72h **Time Frame:** 72hours **Description:** Estimation of AUC from time zero extrapolated to infinity **Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：AUC0-∞ **Time Frame:** 72hours **Description:** Estimation of mean residence time **Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：MRT **Time Frame:** 72hours **Description:** Estimation of apparent volume of distribution **Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：Vd **Time Frame:** 72hours **Description:** Estimation of terminal elimination half-life **Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：t1/2 **Time Frame:** 72hours **Description:** Estimation of clearance when dosed orally **Measure:** Prilinostat Mesylate Pharmacokinetics (PK)：CLz/F **Time Frame:** 72hours #### Secondary Outcomes **Description:** security indicators **Measure:** Evaluation of the pharmacodynamic (PD) characteristics of single/multiple oral doses of ZL-82 tablets in healthy humans **Time Frame:** Day 16 **Description:** security indicators **Measure:** To evaluate the effect of ZL-82 tablets on QT/QTc interval in healthy subjects after single-dose administration. **Time Frame:** Day 16 **Description:** security indicators **Measure:** To evaluate the effect of ZL-82 tablets on ECG parameters (ΔQTcF/ΔΔQTcF and HR, PR, QRS intervals) in healthy subjects, as well as the effect on T wave morphology and U wave. **Time Frame:** Day 16 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Those who can understand the informed consent form, voluntarily participate in the trial and sign the informed consent form. 2. Male or female; aged between 18 and 50 years old (including 18 and 50 years old). 3. Male subjects weigh ≥50kg, female subjects weigh ≥45kg, body mass index (BMI) between 19.0\~26.0kg/m2, BMI = weight (kg)/height 2 (m2), including boundary values. 4. The subject can communicate well with the researcher and complete the trial in compliance with the requirements of the protocol. Exclusion Criteria: - Subjects who meet any of the following criteria will be excluded from the trial: Current medical history, past medical history, and recent medication history: 1. Those who have a history of severe systemic diseases (including cardiovascular system, digestive system, urinary system, respiratory system, etc.), mental illness, and drug dependence; 2. Have a history of structural heart disease, heart failure, myocardial infarction, angina pectoris, torsade de pointes, ventricular tachycardia, QT prolongation syndrome or symptoms of QT prolongation syndrome (such as syncope) , convulsions) and family history (proven hereditary or close relatives died suddenly due to cardiac causes when young); 3. Physical examination, vital signs, laboratory examination items and test-related examinations and tests during the screening period or baseline period (for example: chest X-ray examination, abdominal color ultrasound, blood pregnancy test, ANA examination, gamma-interferon release Test, 12-lead electrocardiogram, etc.) with abnormal results and clinical significance; 4. Patients with a history of lipid metabolism defects, such as: familial hyperlipidemia, lipoid nephropathy, or patients with acute pancreatitis accompanied by hyperlipidemia; 5. Nervous/psychiatric, respiratory system, cardiovascular system, digestive tract system, blood and lymphatic system, endocrine system, musculoskeletal system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the test results during screening By; 6. Those with allergies, or those with a history of food or drug allergies or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) that are clinically significant as determined by the researcher; or those who are known to be allergic to JAK inhibitors or to the test Those who are allergic to the excipients contained in the medicine; 7. Those who have suffered from clinically significant diseases or undergone major surgeries within 3 months before screening; 8. Those who suffered from acute diseases within 2 weeks before screening; those who had clinically significant infections within 3 months before screening (such as upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.); those who had any evidence of infection within 7 days before screening (such as Fever, cough, sputum, headache, etc.); those with a history of herpes simplex infection or recurrent (\>1 time) herpes zoster or disseminated herpes zoster; 9. Those with a history of dysphagia or any gastrointestinal system disease (or gastrointestinal resection, etc.) that affects drug absorption; 10. Those who have donated blood within 3 months before screening, or those who plan to donate blood during this trial, or those who have had blood transfusion or blood loss ≥ 200mL within 4 weeks before the trial; 11. Those who have participated in 4 or more clinical trials as subjects in the past year; or those who have participated in any clinical trials as subjects within 3 months before participating in this trial; 12. Those who have a history of drug abuse within 5 years before screening or have used drugs within 3 months before screening; 13. Concomitant use of strong inducers of liver metabolic enzymes (such as: omeprazole, barbiturates, carbamazepine, aminoglutethimide, griseofulvin, promethazine) within 4 weeks (28 days) before screening esters, phenytoin, gramide, rifampicin, sulfinpyrazone, roxithromycin, etc.); those who have taken any drug known to cause QT/QTc interval prolongation within 4 weeks (28 days) before screening or have Medications that pose a risk of torsade de pointes (TdP); 14. Those who have been vaccinated within 8 weeks before screening, or plan to be vaccinated during the study or within 8 weeks after the last dose of study drug; 15. Those who have a history of fainting from blood and needles and cannot tolerate blood collection with intravenous indwelling needles; Health status: 16. Those whose 12-lead electrocardiogram during the screening period or baseline period has the following results: QTcF interval corrected according to Fridericia's formula \>450ms; or those whose electrocardiogram is abnormal and the researcher believes that the abnormality is clinically significant (including but not limited to complete left bundle branch or right bundle branch block; second or third degree atrioventricular block (AVB); sustained atrial or ventricular arrhythmias; two consecutive ventricular premature contractions; ST-segment elevation pattern and myocardial ischemia Consistent; evidence of previous myocardial infarction (MI), left ventricular hypertrophy (LVH), or more than mild nonspecific ST-T wave changes; any features that make QT assessment unreliable, including flattened T waves); 17. Those with systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg during the screening period or baseline period; 18. Laboratory test results during the screening period or baseline period that the researcher considers to be abnormal and clinically significant, including but not limited to: 1. Abnormal renal function during the screening period or baseline period: serum creatinine \> upper limit of normal (ULN) or glomerular filtration rate (GFR, calculated by CKD-EPI formula) \<90mL/min/1.73m2; 2. Direct bilirubin and total bilirubin\>1.5xULN; 19. Those who are positive for hepatitis B virus surface antigen and/or positive for hepatitis B virus e antigen, positive for hepatitis C virus antibodies, positive for human immunodeficiency virus antibodies, or have abnormal Treponema pallidum antibodies during the screening period; 20. Those who have a positive alcohol breath test during the screening period or baseline period, or a positive urine drug abuse screen; Lifestyle restrictions: 21. Have special requirements for diet and cannot comply with the diet and corresponding regulations provided by clinical research institutions; 22. Those who cannot control special diets (including dragon fruit, mango, grapefruit and/or xanthine diets, caffeinated foods or beverages, etc.) from 48 hours before the first dose to the end of the study; 23. Those who have taken special diets or exercised strenuously within 48 hours before the first dose, or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.; 24. Regular drinkers within 6 months before administration or during the trial, that is, drinking more than 21 units (men) or 14 units (women) of alcohol per week (1 unit = 360mL beer or 45mL liquor with an alcohol content of 40%) or 150mL wine); 25. Those who smoked more than 5 cigarettes per day in the 3 months before administration, or who will use any tobacco products during the trial; contraception: 26. Pregnant or lactating women or those with positive blood pregnancy test results; 27. Those who have used long-acting estrogen or progesterone injections or implants within 6 months before screening; 28. Women of childbearing age who had unprotected sex with their partners within 14 days before screening; 29. Male or female subjects of childbearing potential do not agree to use effective contraceptive methods from the time of signing the informed consent form to 6 months after the last dose. Other standards: 30. Subjects who the researcher believes have poor compliance or have any factors that are not suitable for participating in this trial; 31. Relevant personnel of the research center and their family members; 32. Vulnerable subjects such as students and subordinates of researchers and employees of sponsors; 33. Subjects may not be able to complete this trial due to other reasons. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hong Wang, Bachelor **Phone:** 0533-7698395 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** jie hou, Doctor **Phone:** 05337698395 **Role:** CONTACT #### Locations **Location 1:** **City:** Zibo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Suqin Fang, bachelor - **Phone:** 18553376165 - **Role:** CONTACT ***Contact 2:*** - **Name:** Hong Wang, bachelor - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Jie Hou, Doctor - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Peking University Medical Shandong Hospital of Traditional Chinese Medicine **State:** Shandong **Status:** RECRUITING **Zip:** 255000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432725 **Brief Title:** Joining Under-connected Networks to Optimize "Salud" (Health) ("JUNTOS") **Official Title:** Enhancing HIV Prevention and Treatment Referral and Engagement Among Latino Men Who Have Sex With Men (MSM): A Pilot Hybrid Effectiveness-Implementation Trial of the JUNTOS Referral Network #### Organization Study ID Info **ID:** 20230443 #### Organization **Class:** OTHER **Full Name:** University of Miami #### Secondary ID Infos **ID:** R34MH134670 **Link:** https://reporter.nih.gov/quickSearch/R34MH134670 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Mental Health (NIMH) #### Lead Sponsor **Class:** OTHER **Name:** University of Miami #### Responsible Party **Investigator Affiliation:** University of Miami **Investigator Full Name:** Audrey Harkness **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this study is to evaluate the JUNTOS Referral Network as an implementation strategy to enhance the reach of HIV-prevention and treatment services to Latino gay, bisexual, and other men who have sex with men (MSM). ### Conditions Module **Conditions:** - Hiv ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 245 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this group will get access to the JUNTOS Referral Network website/app through the 6-month follow up (HIV test counselors) and 3-month follow up (Latino MSM). **Intervention Names:** - Behavioral: JUNTOS **Label:** JUNTOS **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in this group will get access to the referral sheet through the 6-month follow up (HIV test counselors) and 3-month follow up (Latino MSM). **Intervention Names:** - Behavioral: Referral Sheet **Label:** Referral Sheet - HIV test counselors **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - JUNTOS **Description:** HIV test counselor and Latino MSM participants will be given access to the JUNTOS website/app, which shows information about local HIV and ancillary services. HIV test counselor participants will also be given access to a training video explaining how to use the JUNTOS website/app. HIV test counselors are encouraged to use the website/app for approximately 10 minutes at least once a week when meeting with Latino MSM testing clients. Latino MSM are encouraged to use the website/app to locate HIV and ancillary services as needed. **Name:** JUNTOS **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Referral Sheet - HIV test counselors **Description:** HIV test counselor and Latino MSM participants will be given access to referral sheet, which is a list of local HIV and ancillary services. HIV test counselors are encouraged to use the referral sheet for approximately 10 minutes at least once a week when meeting with Latino MSM testing clients. Latino MSM are encouraged to use the referral sheet to locate HIV and ancillary services as needed. **Name:** Referral Sheet **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The number of Latino MSM participants who indicated using a biomedical HIV prevention/treatment. **Measure:** Use of Biomedical HIV Prevention/Treatment **Time Frame:** 3-months **Description:** The Referral Fidelity Questionnaire, developed for this study, has scores that range from 0% to 100%. Higher scores indicate more Latino MSM clients were referred to biomedical HIV Prevention/Treatment. **Measure:** Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment **Time Frame:** 3-months #### Secondary Outcomes **Description:** The Referral Fidelity Questionnaire, developed for this study, has scores that range from 0% to 100%. Higher scores indicate more Latino MSM clients referred to biomedical HIV Prevention/Treatment. **Measure:** Percentage of Latino MSM Referral for Biomedical HIV Prevention/Treatment **Time Frame:** 6-months **Description:** This will be measured by a self-report question of Latino MSM's HIV status. **Measure:** HIV acquisition, measures by self-report **Time Frame:** 3-months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: HIV Test counselors: * 18 years of age or older * Certified as an HIV test counselor in Miami-Dade County or Broward County (at the time of enrollment) * Working or volunteering as an HIV test counselor in Miami-Dade County or Broward County and report testing 1 or more Latino MSM client per week (at the time of enrollment) * Plans to continue working or volunteering as an HIV test counselor in Miami-Dade County or Broward County for the next 6 months * Reports suboptimal fidelity to pre-exposure prophylaxis (PrEP) referral guidelines (\<80% fidelity) * Willing and able to recruit 4-5 Latino MSM testing clients into the study Latino MSM: * 18 years of age or older * Identifies as Latino/a/x or Hispanic * Identifies as a sexual minority man or reports being a man who has sex with men * Speaks English and/or Spanish * Received an HIV test from an HIV test counselor participating in the study * Lives in Miami-Dade County, Broward County, or Palm Beach County and anticipates living there for the next three months Exclusion Criteria: HIV test counselors: * Unable to consent * Study personnel unable to verify HIV test counselor role in Miami-Dade County or Broward County (e.g., confirmation of where they work/volunteer as HIV test counselor, location they state they provide services doesn't exist or does not provide HIV testing services) * Works as an HIV test counselor in an incarceration/prison setting (i.e., clients are prisoners) Latino MSM: * Unable to consent **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Audrey Harkness, PhD **Phone:** 786-401-2846 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nicole Altenberg, BS **Phone:** 786-401-2846 **Role:** CONTACT #### Locations **Location 1:** **City:** Coral Gables **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nicole Altenberg, BS - **Phone:** 786-401-2846 - **Role:** CONTACT ***Contact 2:*** - **Name:** Audrey Harkness, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Miami **State:** Florida **Zip:** 33146 #### Overall Officials **Official 1:** **Affiliation:** University of Miami **Name:** Audrey Harkness, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432712 **Brief Title:** Comparison of Post Operative Endodontic Pain in Patients With Irreversible Pulpitis Treated With and Without Dexamethasone. **Official Title:** Comparison of Post Operative Endodontic Pain in Patients With Irreversible Pulpitis Treated With and Without Dexamethasone. #### Organization Study ID Info **ID:** FUCDCLINIC-2404 #### Organization **Class:** OTHER **Full Name:** Foundation University Islamabad ### Status Module #### Completion Date **Date:** 2025-06-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Foundation University Islamabad #### Lead Sponsor **Class:** OTHER **Name:** Shoaib Rahim #### Responsible Party **Investigator Affiliation:** Foundation University Islamabad **Investigator Full Name:** Shoaib Rahim **Investigator Title:** Assistant professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Root canal procedure is a common procedure in dentistry. Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain. Potential Solution: The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain. Research Goal: Pain score of patients treated with dexamethasone infiltration will be less compared to patients treated with NSAIDS alone after canal instrumentation. **Detailed Description:** Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain. The peak inflammatory response occurs after 24 - 48 hours of root canal instrumentation. As management of post-endodontic pain is still a challenge for clinicians several drugs which include NSAIDs, acetaminophen, opioids and steroids are used to reduce the inflammatory response. Corticosteroids possess anti-inflammatory efficacy, and they prevent the production and release of inflammatory mediators at the site of tissue injury thus reducing the signs \& symptoms of inflammation such as pain, swelling \& loss of function. Dexamethasone is a potent corticosteroid that has the ability to reduce the production of proinflammatory cytokines. Dexamethasone can be administered orally, or as an intraosseous, intra ligament periapical \& intracanal injection. Dexamethasone is effective in alleviating pain in first 24 hours post endodontic treatment. Previous research on the effect of dexamethasone injection on post-endodontic treatment pain in patients presenting with necrotic pulp treated with single visit endodontic treatment reported 25% post operative pain occurrence and 9% when treated with dexamethasone. Study Goal : The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain as compared to the prescription of NSAIDs only. If dexamethasone infiltration is effective in pain relief after endodontic treatment, it can be a useful adjunct in managing patients presenting with acute pulpal pain. ### Conditions Module **Conditions:** - Pain **Keywords:** - Postoperative Pain - Root canal therapy - Dexamethasone - Pulpitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive dexamethasone infiltration or only analgesic therapy. They will remain in their assigned group throughout the study. ##### Masking Info **Masking:** NONE **Masking Description:** Interventional or control group will be selected randomly through sealed envelope by an independent researcher not involved in the study. **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this arm will receive routine root canal treatment with a prescription of NSAIDs post operatively. **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Participants in this arm will receive routine root canal treatment along with 2.5ml of dexamethasone 4mg/ml peri apical infiltration with a prescription of NSAIDs post operatively. **Intervention Names:** - Drug: Dexamethasone 4mg **Label:** Experimental **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** 2.5ml of Dexamethasone 4mg/ml will be administered via periapical infiltration with a 23 gauge needle to the experimental group. **Name:** Dexamethasone 4mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The patient's pain response before treatment will be recorded using visual analogue scale 0-10.Pain score of 3 and less than 3 will be categorized as no postoperative pain and score greater than 3 will be categorized as post operative pain. **Measure:** post operative pain **Time Frame:** 12 hours, 24 hours and 1 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients of age 18-50 years * Maxillary molar and premolar teeth * Pt diagnosed with irreversible pulpitis with or without apical periodontitis Exclusion Criteria: * Teeth with calcified canals. * Teeth with incompletely formed apices. * Teeth requiring retreatment. * Taking analgesics, anti-inflammatory, or tri-cyclic anti-depressants for their medical conditions. * Teeth with grade II or III mobility (more than 2 mm) * Pregnant patients * Pt who are immunocompromised (uncontrolled diabetes mellitus, renal impairment) **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** zainab butt, BDS **Phone:** +93225667847 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rozina Nazir, FCPS **Phone:** +92 3215376612 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Suresh N, Nagendrababu V, Koteeswaran V, Haritha JS, Swetha SD, Varghese A, Natanasabapathy V. Effect of preoperative oral administration of steroids in comparison to an anti-inflammatory drug on postoperative pain following single-visit root canal treatment - a double-blind, randomized clinical trial. Int Endod J. 2021 Feb;54(2):198-209. doi: 10.1111/iej.13416. Epub 2020 Nov 12. **PMID:** 32976660 **Citation:** Yeganegi S, Fazelian N, Layegh Nejad MK, Manzouri L. Comparison of the Efficacy of Dexamethasone and Methylprednisolone in Infiltration Injection for Postendodontic Pain in Patients with Necrotic Pulp: A Randomized Controlled Clinical Trial. Pain Res Manag. 2022 Feb 23;2022:4163120. doi: 10.1155/2022/4163120. eCollection 2022. **PMID:** 35251416 **Citation:** Aksoy F, Ege B. The effect of pretreatment submucosal injections of tramadol and dexamethasone on post-endodontic pain in mandibular molar teeth with symptomatic irreversible pulpitis: a randomized controlled clinical trial. Int Endod J. 2020 Feb;53(2):176-185. doi: 10.1111/iej.13246. Epub 2019 Nov 28. **PMID:** 31702056 **Citation:** Nogueira BML, Silva LG, Mesquita CRM, Menezes SAF, Menezes TOA, Faria AGM, Porpino MTM. Is the Use of Dexamethasone Effective in Controlling Pain Associated with Symptomatic Irreversible Pulpitis? A Systematic Review. J Endod. 2018 May;44(5):703-710. doi: 10.1016/j.joen.2018.02.006. Epub 2018 Mar 20. **PMID:** 29571913 **Citation:** Yavari HR, Jafari F, Jamloo H, Hallaj-Nezhadi S, Jafari S. The Effect of Submucosal Injection of Corticosteroids on Pain Perception and Quality of Life after Root Canal Treatment of Teeth with Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2019 May;45(5):477-482. doi: 10.1016/j.joen.2019.01.005. Epub 2019 Mar 23. **PMID:** 30910353 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003788 - Term: Dental Pulp Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: LOW - As Found: Unknown - ID: M14525 - Name: Pulpitis - Relevance: HIGH - As Found: Pulpitis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M6984 - Name: Dental Pulp Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011671 - Term: Pulpitis ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: HIGH - As Found: Children - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003907 - Term: Dexamethasone ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432699 **Acronym:** MOPS **Brief Title:** Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split Mouth Clinical Study **Official Title:** Rate of Canine Retraction and Pain Perception Following Micro-osteoperforation- a Split #### Organization Study ID Info **ID:** FF/FUMC/215-372Phy/23 #### Organization **Class:** OTHER **Full Name:** Foundation University Islamabad ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Foundation University Islamabad #### Responsible Party **Investigator Affiliation:** Foundation University Islamabad **Investigator Full Name:** Shoaib Rahim **Investigator Title:** ZAINAB BUTT **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** DEFINITION: A short description of clinical study , including a brief statement of clinical study's hypothesis, written in language intended for the lay public Limit: 5000 CHARACTERS **Detailed Description:** Definition: Extended description of the protocol ,including more technical information(as compared to the brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. Limit:32,000 characters. For Patient Registries: Also describe the applicable registry procedures and other quality factors (for examples, third party certification, on site audit). In particular , summarize any procedures implemented as part of the patient registry, including , but not limited to the following: * Quality assurance plan that addresses data validation and registry procedures, including and plans for site monitoring and auditing * Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. * Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources( for example, medical records, paper or electronic case reports forms, or interactive voice response systems) * Data Dictionary that contains detailed descriptions of each variable used by the registry, including, including the source of the variable, coding information if used (for example World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant. * STANDARD OPERATING PROCEDURE TO ADDRESS REGISTRY REGISTRY OPERATIONS AND ANALYSISACTIVITIES, SUCH AS PATIENT RECRUITMENT DATA COLLECTION,DATA MANAGEMENT., DATA ANALYSIS, reporting for adverse events, and change management. * Sample Size Assessment to specify the number of participants or participate years necessary to demonstrate an effect. * Plan for missing data to address situations where variable are reported a missing , unavailable non-reported, interpretable, or considered missing because of data inconsistency or out-of-range results. * Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives , as specified in the study protocol or plan ### Conditions Module **Conditions:** - Pain - Rate of Canine Retraction **Keywords:** - MOP ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either MOPS or no Mops ##### Masking Info **Masking:** NONE **Masking Description:** Participants will be randomly assigned to receive Micro-osteoperforation and the other side will be control. **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this arm will receive no MOP treatment **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** participants in this arm will receive MOPS intervention **Intervention Names:** - Other: micro osteoperforation **Label:** Experimental **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** one side used for mops while other side will be control in same patient **Name:** micro osteoperforation **Other Names:** - Placebo/Controlled **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** patient after undergoing micro-osteoperforation will be aske to measure pain and check rate of canine retraction **Measure:** pain will be measured after intervention of visual analogue scale **Time Frame:** three months since the MOPS ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - 1. Age range around 15-40 years. 2. Patients which have class I malocclusion or class II Div I malocclusion and include first premolar extraction as part of treatment plan.. 3. No orthodontic treatment previously 4. Radiographic evidence showing no bone loss 5. History showing no periodontal disease. 6. History showing no systemic disease. 7. Probing depth less than 4 mm across the entire dentition 8. No active carious lesion or any sign of gingivitus Exclusion Criteria: 1. Presence of any craniofacial abnormality. 2. Any history of bleeding disorders. 3. Poor oral hygiene. 4. Use of bisphosphonates, analgesics, anti-inflammatory drugs, corticosteroids for more than three months prior to treatment or during treatment. 5. Active diseases such as metabolic bone disease. 6. Malocclusions requiring surgical intervention. 7. Smoker - **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 14 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rozina Nazir, FCPS **Phone:** +92 3215376612 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** zainab butt, BDS **Phone:** +93225667847 **Role:** CONTACT #### Locations **Location 1:** **City:** Islamabad **Country:** Pakistan **Facility:** Foundation University Islamabad **State:** Punjab **Zip:** 04403 ### References Module #### References **Citation:** 1. Kundi, I., Alam, M. K., & Shaheed, S. (2020). Micro-osteo perforation effects as an intervention on canine retraction. The Saudi dental journal, 32(1), 15-20. https://doi.org/10.1016/j.sdentj.2019.05.009 2. Husain S, Sundari S. Comparison of the effectiveness of piezocision-aided canine retraction augmented with micro-osteoperforation: a randomized controlled trial. Angle Orthod. 2023 Oct 16. doi: 10.2319/052323-370.1. Epub ahead of print. PMID: 37839802. 12 3. Aboalnaga AA, Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split- mouth randomized controlled trial. Prog Orthod. 2019 Jun;20(1) 21. doi:10.1186/s40510-019-0274-0. PMID: 31155698; PMCID: PMC6545296. 4. Bolat Gümüş, E., Kınsız, E. Effects of miniscrew-facilitated micro- osteoperforations on the rate of orthodontic tooth movement. J Orofac Orthop 84 (Suppl 2), 104-110 (2023). 5. Martina K., Kumar P., Misra V., Attri S., Yadav A., Sam R., Kumar R.. To evaluate the rate of canine retraction and pain perception following micro- osteoperforation - a split-mouth clinical study. Australasian Orthodontic Journal. 2022;38(2): 388-395 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432686 **Brief Title:** Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS **Official Title:** Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS - a Pilot Study #### Organization Study ID Info **ID:** MS-fMRI-TENS #### Organization **Class:** OTHER **Full Name:** University Medical Center Groningen ### Status Module #### Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Medical Center Groningen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Transcutaneous Electrical Nerve Stimulation (TENS) is a treatment that could potentially reduce walking problems and fatigue in persons with Multiple Sclerosis. However, extensive use of TENS in a clinical setting is hindered by a lack of neurophysiological understanding of the effects of TENS. The primary objective of this pilot study is therefore to investigate the effects of TENS on brain activity in pwMS measured with fMRI. **Detailed Description:** This study is an exploratory study to see if we can detect changes in fMRI activity during TENS in persons with MS. This is a randomized, single-blind crossover design. Subjects will undergo an MRI scan while they receive sham stimulation of the tibialis anterior, active stimulation of the tibialis anterior, stimulation of the quadriceps, perform continuous movements of the foot (plantar \& dorsiflexion) and a combination of stimulation of the tibialis anterior and movement of the foot. This study will include 15 subjects with relapsing remitting or progressive MS and 15 healthy controls. Blood-oxygen-level-dependent (BOLD) activation changes and the interaction networks before, during and after active TENS and differences in activation due to stimulation on quadriceps vs. tibialis anterior, stimulation on tibialis anterior vs plantar/dorsiflexion and stimulation on tibialis anterior vs stimulation combined with plantar/dorsiflexion. This will be compared between pwMS and healthy controls. This study can add to the limited knowledge and possibly help to personalize and implement TENS in the clinic. ### Conditions Module **Conditions:** - Walking Difficulties, Fatigue, Transcutaneous Electrical Nerve Stimulation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** * sham stimulation of the tibialis anterior, * active stimulation of the tibialis anterior, * active stimulation of the quadriceps, * continuous movement of the foot (plantar \& dorsiflexion), * a combination of sham stimulation of the tibialis anterior and movement of the foot, * a combination of stimulation of the tibialis anterior and movement of the foot. The order of these conditions is randomized. ##### Masking Info **Masking:** SINGLE **Masking Description:** All participants receive both active and sham TENS. Subjects will be told they will get two types of stimulation but they are not being told that one is 'sham' and the other 'active', to minimalize a placebo effect. Researchers are not blinded, but also interacting minimally with the participant while they are lying in the scanner. **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Transcutaneous Electrical Nerve Stimulation **Label:** sham stimulation of the tibialis anterior **Type:** SHAM_COMPARATOR #### Arm Group 2 **Intervention Names:** - Device: Transcutaneous Electrical Nerve Stimulation **Label:** active stimulation of the tibialis anterior **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Device: Transcutaneous Electrical Nerve Stimulation **Label:** active stimulation of the quadriceps **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Behavioral: Movement **Label:** continuous movement of the foot (plantar & dorsiflexion) **Type:** ACTIVE_COMPARATOR #### Arm Group 5 **Intervention Names:** - Device: Transcutaneous Electrical Nerve Stimulation - Behavioral: Movement **Label:** a combination of sham stimulation of the tibialis anterior and movement of the foot **Type:** SHAM_COMPARATOR #### Arm Group 6 **Intervention Names:** - Device: Transcutaneous Electrical Nerve Stimulation - Behavioral: Movement **Label:** a combination of active stimulation of the tibialis anterior and movement of the foot **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - a combination of active stimulation of the tibialis anterior and movement of the foot - a combination of sham stimulation of the tibialis anterior and movement of the foot - active stimulation of the quadriceps - active stimulation of the tibialis anterior - sham stimulation of the tibialis anterior **Description:** Transcutaneous electrical nerve stimulation (TENS) is a safe, relatively cheap, and non-painful stimulation of the peripheral sensory and motor nerves. The stimulator is easy to operate and pwMS can apply the stimulation themselves at home. This makes TENS an interesting tool to augment sensory input. A high frequency and long pulse duration is used. **Name:** Transcutaneous Electrical Nerve Stimulation **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - a combination of active stimulation of the tibialis anterior and movement of the foot - a combination of sham stimulation of the tibialis anterior and movement of the foot - continuous movement of the foot (plantar & dorsiflexion) **Description:** Participants are instructed to perform plantar- and dorsi-flexion contraction in a relatively slow tempo. The movement of the ankle is measured by an MRI-compatible potentiometer and participants receive feedback of this movement on the screen inside the scanner. **Name:** Movement **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Blood level detection activation (BOLD) changes and interaction networks before, during and after active TENS and differences in activation due to stimulation on quadriceps vs. tibialis anterior, stimulation on tibialis anterior vs plantar/dorsiflexion and stimulation on tibialis anterior vs stimulation combined with plantar/dorsiflexion. We focus on the thalamus (integration station of sensory input), sensory cortex (sensory awareness) and motor cortices (sensorimotor integration). **Measure:** BOLD activation due to TENS **Time Frame:** 1 hour fMRI scan ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age: 18-65 years * EDSS score \< 7 Exclusion Criteria: * metal or electrical implants * BMI \> 40 * claustrophobia * being pregnant * having a psychiatric disorder * having cognitive or communication problems which reduces the capacity to understand instructions * having a neurological disorder other than MS * having cardiac arrhythmia **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nikki Dreijer **Phone:** 0625647172 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Inge Zijdewind **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8364 - Name: Fatigue - Relevance: HIGH - As Found: Fatigue ### Condition Browse Module - Meshes - ID: D000005221 - Term: Fatigue ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M251057 - Name: TEMPO - Relevance: LOW - As Found: Unknown - ID: M186190 - Name: Aluminum hydroxide, magnesium hydroxide, simethicone drug combination - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432673 **Acronym:** Attractive 2 **Brief Title:** The Attractive 2 Trial - Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers **Official Title:** The Attractive 2 Trial - An Open-label, Randomised, 2-period Cross-over Trial to Assess the Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers #### Organization Study ID Info **ID:** ATR-258-trial-2 #### Organization **Class:** INDUSTRY **Full Name:** Atrogi AB #### Secondary ID Infos **ID:** 2023-508797-28-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Atrogi AB #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a single-centre, open-label, randomised, 2-period cross-over, Phase 1 comparative trial to assess the ATR-258 pharmacokinetic (PK) parameters of an oral capsule formulation in comparison with an oral solution formulation, both given as single doses to healthy volunteers. The order of treatment, i.e., the treatment sequence capsule - solution or solution - capsule, will be randomised. ### Conditions Module **Conditions:** - Type2diabetes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 21 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive a single dose of ATR-28 in the order Oral capsule - Oral solution with a washout period in between. **Intervention Names:** - Drug: ATR-258 Oral solution - Drug: ATR-258 Oral capsule **Label:** Arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive a single dose of ATR-28 in the order Oral solution - Oral capsule with a washout period in between. **Intervention Names:** - Drug: ATR-258 Oral solution - Drug: ATR-258 Oral capsule **Label:** Arm 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1 - Arm 2 **Description:** Oral solution **Name:** ATR-258 Oral solution **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm 1 - Arm 2 **Description:** Oral capsule **Name:** ATR-258 Oral capsule **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Area under the plasma concentration versus time curve (AUC) **Time Frame:** 48 hours **Measure:** Peak Plasma Concentration (Cmax) **Time Frame:** 48 hours #### Secondary Outcomes **Description:** Tmax **Measure:** Time to maximum plasma concentration (Tmax) **Time Frame:** 48 hours **Measure:** Half life in plasma (T1/2) **Time Frame:** 48 hours **Measure:** Apparent total body clearance following extravascular administration (CL/F) **Time Frame:** 48 hours **Measure:** Volume of distribution following extravascular administration (Vz/F) **Time Frame:** 48 hours **Description:** Frequency, intensity and seriousness of reported adverse events **Measure:** Adverse events **Time Frame:** 7 days post last dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Provision of informed consent * Body mass index ≥ 18.5 and ≤ 30.0 * Medically healthy participant * Willing to use of double barrier contraceptive method if of childbearing potential Exclusion Criteria: * History or clinical manifestation of any clinically significant disease * History of dysphagia or any other swallowing disorder * Current smokers or users of nicotine products * History or manifestation of drug abuse, alcohol abuse and/or excessive intake of alcohol **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Torbjörn Ström **Phone:** +468590 745 80 **Role:** CONTACT #### Locations **Location 1:** **City:** Uppsala **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Måns Jergil - **Phone:** +46 18 30 33 00 - **Role:** CONTACT **Country:** Sweden **Facility:** Clinical Trial Consultants AB **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Atrogi AB **Name:** Erik Waara **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432660 **Acronym:** PROMPT **Brief Title:** Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients **Official Title:** Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT) #### Organization Study ID Info **ID:** Pro00115893 #### Organization **Class:** OTHER **Full Name:** Duke University ### Status Module #### Completion Date **Date:** 2029-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Duke University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This prospective registry study will evaluate doses utilized in eye plaque brachytherapy for the treatment of ocular melanoma and their associated outcomes. The goal of this study is to evaluate if lower doses of radiation can maintain high local control rates while minimizing the toxicities related to radiation therapy. ### Conditions Module **Conditions:** - Ocular Melanoma **Keywords:** - eye plaque brachytherapy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 5 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Patients 18 years of age or older with unilateral primary choroidal melanoma **Intervention Names:** - Other: Data collection **Label:** Ocular Melanoma ### Interventions #### Intervention 1 **Arm Group Labels:** - Ocular Melanoma **Description:** Information about radiation therapy via eye plaque brachytherapy and follow up **Name:** Data collection **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Number of disease free participants expressed as a percentage of the total number of participants enrolled **Measure:** Percentage of participants with no disease recurrence within the radiation therapy field. **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients 18 years of age or older with unilateral primary choroidal melanoma * Patients with diagnosis of small or medium ocular melanomas amenable to plaque brachytherapy (as determined by treating ocular oncologist). Typically this would include tumors with apical height ≤10mm and basal diameter ≤16mm (small and medium tumors per COMS (Collaborative Ocular Melanoma Study) * Patients with no clinical evidence of metastatic disease as confirmed by negative staging imaging (CT, MRI, and/or ultrasound) * Patients with best-corrected visual acuity in the fellow eye of 20/200 or better * Patients must be treated with IsoAid Eye Physics eye plaques Exclusion Criteria: * Patients whose tumors are circumferential around the optic disc and cannot be adequately covered by the prescription dose are ineligible. * Similarly, patients with extrascleral tumor extension detected during echography or clinical exam, diffuse, ring or multifocal tumors that cannot be encompassed in a single episcleral plaque or tumors judged to be predominantly ciliary body or iris melanoma will be considered ineligible * Previous treatment for ocular melanoma in either eye or treatment of any condition secondary to the tumor are ineligible. * Patients with a history of other primary or metastatic cancers are not eligible, except for non-melanotic skin cancers * Patients with extraocular disease **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population will include adult patients seen at the Duke Eye Center and/or Duke Department of Radiation Oncology who meet the eligibility criteria. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Joan Cahill, BNS RN OCN **Phone:** (919) 668-5211 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Duke University Health System (DUHS) **Name:** Dianda Ayala-Peacock, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Meltsner SG, Rodrigues A, Materin MA, Kirsch DG, Craciunescu O. Transitioning from a COMS-based plaque brachytherapy program to using eye physics plaques and plaque simulator treatment planning system: A single institutional experience. J Appl Clin Med Phys. 2023 May;24(5):e13902. doi: 10.1002/acm2.13902. Epub 2023 Jan 13. **PMID:** 36637797 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018326 - Term: Nevi and Melanomas - ID: D000012878 - Term: Skin Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11528 - Name: Melanoma - Relevance: HIGH - As Found: Melanoma - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12448 - Name: Nevus, Pigmented - Relevance: LOW - As Found: Unknown - ID: M12446 - Name: Nevus - Relevance: LOW - As Found: Unknown - ID: M20470 - Name: Nevi and Melanomas - Relevance: LOW - As Found: Unknown - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T4192 - Name: Ocular Melanoma - Relevance: HIGH - As Found: Ocular Melanoma - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008545 - Term: Melanoma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432647 **Brief Title:** A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105 **Official Title:** ATH-1105 A Phase 1, Double-Blind, Placebo-Controlled, Single-and-Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Male and Female Subjects #### Organization Study ID Info **ID:** ATH-1105-0101 #### Organization **Class:** INDUSTRY **Full Name:** Athira Pharma ### Status Module #### Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Fortrea Holdings, Inc. #### Lead Sponsor **Class:** INDUSTRY **Name:** Athira Pharma #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants. **Detailed Description:** The study is a Phase 1, First-In-Human study consisting of two parts (A and B). Part A will comprise a single-dose, double-blind, placebo-controlled, sequential-group design. Part B will comprise a multiple-dose, placebo-controlled, sequential-group design. ### Conditions Module **Conditions:** - Healthy Volunteers **Keywords:** - ATH-1105 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Part A: ATH-1105 administered once as an oral solution. Part B: ATH-1105 administered once daily as an oral solution for 10 days. **Intervention Names:** - Drug: ATH-1105 **Label:** ATH-1105 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Part A: Placebo administered once as an oral solution Part B: Placebo administered once daily as an oral solution **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ATH-1105 **Description:** ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B. **Name:** ATH-1105 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Safety and tolerability of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG **Measure:** Incidence of Treatment-Emergent Adverse Events **Time Frame:** Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10 **Description:** Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator. **Measure:** Severity of Treatment-Emergent Adverse Events **Time Frame:** Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10 #### Secondary Outcomes **Description:** AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose. **Measure:** Area under the plasma concentration time curve (AUC) **Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 **Description:** Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose. **Measure:** Maximum observed plasma concentration (Cmax) **Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 **Description:** Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose. **Measure:** Time to maximum observed plasma concentration (Tmax) **Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 **Description:** t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose. **Measure:** Half-life (t1/2) **Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 **Description:** Amount of IMP excreted unchanged in the urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose **Measure:** Amount of IMP excreted unchanged in the urine (Ae) **Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 **Description:** Amount of IMP in the urine will be determined from all collected CSF samples from baseline through up to 48 hours post-dose **Measure:** IMP Concentration in Cerebrospinal Fluid **Time Frame:** Will occur at calculated maximum plasma concentration. **Description:** Accumulation Ratio in urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose **Measure:** Accumulation Ratio (AUC) of IMP in Urine **Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 **Description:** Accumulation Ratio in plasma will be determined from all collected plasma samples from baseline through up to 48 hours post-dose **Measure:** Accumulation Ratio (AUC) of IMP in Plasma **Time Frame:** Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Body mass index between 18.0 and 32.0 kg/m2 inclusive. * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check-in or predose on Day 1 * Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception * Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Exclusion Criteria: Medical Conditions: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs * Any of the following: 1. QTcF \>450 ms in males or \>470 ms in females 2. QRS duration \>110 ms 3. PR interval \>220 ms 4. Findings which would make QTc measurements difficult or QTc data uninterpretable. 5. History of additional risk factors for torsades de pointes * Confirmed systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, and pulse rate \>100 or \<40 beats per minute. * Positive hepatitis panel and/or positive human immunodeficiency virus test * Part B only: Current psychiatric disorder, suicidal ideation in the previous 2 years (as assessed by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or a lifetime suicide attempt. Prior/concomitant therapy: * Administration of any vaccine in the 30 days prior to dosing. * Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes * Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing * Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in * Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Javier San Martin, MD **Phone:** 425-620-8501 **Role:** CONTACT #### Locations **Location 1:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jhande Gardiner - **Phone:** 214-647-9399 - **Role:** CONTACT ***Contact 2:*** - **Name:** Adeyemi Gbohunmi, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Fortrea Clinical Research Unit Inc. **State:** Texas **Status:** RECRUITING **Zip:** 75247 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432634 **Acronym:** CPRP **Brief Title:** Effects of CPRP on Patients Undergoing Lung Resection **Official Title:** Effects of Comprehensive Pulmonary Rehabilitation Programs (CPRP) on Patients Undergoing Lung Resection: a Randomized Controlled Trial #### Organization Study ID Info **ID:** 202400512B0 #### Organization **Class:** OTHER **Full Name:** Chang Gung Memorial Hospital ### Status Module #### Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chang Gung Memorial Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this project is to investigate the effectiveness of implementing a Comprehensive Pulmonary Rehabilitation Program (CPRP) in patients undergoing lung resection surgery. The CPRP encompasses a training regimen combining aerobic exercise, resistance exercises, breathing exercises, and home activities, specifically tailored for patients with limited exercise capacity and impaired lung function. The study seeks to understand the physiological and biological effects of the CPRP in this patient population. **Detailed Description:** Background: Elderly patients with compromised lung function or poor health conditions undergoing lung resection surgery face an increased risk of postoperative pulmonary complications. Pulmonary rehabilitation programs play a crucial role in enhancing recovery after surgery, having been shown to reduce postoperative pulmonary complications and enhance patients' pre- and post-operative exercise capacity, functional performance, and quality of life. However, due to the heterogeneity of interventions in pulmonary rehabilitation programs, the optimal timing, methods, or duration of exercise training for lung resection patients remain unclear. Additionally, there is a lack of comprehensive research on the changes and impacts of biomarkers in the blood of lung resection patients following intervention with pulmonary rehabilitation programs. Objectives: This study aims to investigate the physiological and biological effects of a comprehensive pulmonary rehabilitation program in lung resection surgery patients with limited exercise capacity and impaired lung function. Research Methods: This study adopts an open label, randomized, parallel design, intending to recruit 96 lung resection surgery participants divided into a control group receiving standard care and an experimental group receiving the comprehensive pulmonary rehabilitation programs. The intervention period spans 1-2 weeks pre-surgery, during hospitalization, and 3-6 weeks post-discharge. Participants will undergo four assessments at randomization (baseline, T0), one day pre-surgery (T1), the day of discharge post-surgery (T2), and at trial completion (T3). The primary endpoint is the six-minute walk test. Secondary endpoints include lung function, lung expansion volume, respiratory muscle strength, incidence of postoperative complications and pulmonary complications, chest tube duration, length of hospital stay, quality of life (EORTC QLQ-C30), and pain. Exploratory endpoints involve inflammation-related and immune-related biomarkers. Expected Impact: This study will provide valuable insights into the physiological and biological effects of a comprehensive pulmonary rehabilitation programs for lung resection surgery patients. Results may contribute to improving patient outcomes and advancing academic understanding and clinical guidelines in this field. ### Conditions Module **Conditions:** - Rehabilitation **Keywords:** - lung resection surgery - comprehensive pulmonary rehabilitation programs - six-minute walk test - quality of life - biomarkers ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Masking Description:** The blinding of patients to their treatment group allocation is unattainable owing to the inherent nature of the exercise intervention. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 96 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants randomize to the standard care group (SC) receive the standard care already established in Chiayi Chang Gung Memorial Hospital. Standard care comprises one therapeutic education session conducted by a respiratory therapist 1-2 weeks before surgery. **Intervention Names:** - Other: Standard care **Label:** standard care group **Type:** SHAM_COMPARATOR #### Arm Group 2 **Description:** Participants randomize to the comprehensive pulmonary rehabilitation program group (CPRP) undergo an evidence-based and hospital-based comprehensive pulmonary rehabilitation program developed by the research group. This program is administered in addition to the standard care provided and spans across the preoperative, peri-operative, and postoperative periods, covering a total of 1-2 weeks preoperatively and 3-6 weeks postoperatively. CPRP involves warm-up and cool-down exercises, the aerobic training, and the resistance training. Additionally, participants are encouraged to continue exercising at home or in community sports facilities. **Intervention Names:** - Other: Standard care - Other: Comprehensive pulmonary rehabilitation programs **Label:** comprehensive pulmonary rehabilitation program group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - comprehensive pulmonary rehabilitation program group - standard care group **Description:** The pre-operative educational session has a duration of 40 minutes and covers pre-operative education, breathing exercises (diaphragmatic breathing, deep breathing techniques and sustained maximal inflation), and airway clearance techniques (directed cough, huffing, and chest physiotherapy). Patients are instructed to perform these techniques ten times per waking hour, every day. The in-patient peri-operative session incorporates intermittent positive pressure breathing inhalation (IPPB) administered for 15 minutes twice daily. Inhalation therapy involving mucolytics and bronchodilators is administered three times per day, and early mobilization is encouraged until discharge. Upon discharge, participants are encouraged to continue practicing breathing exercises, deep breathing techniques, and maintaining an active level of activity. **Name:** Standard care **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - comprehensive pulmonary rehabilitation program group **Description:** 1. Warm-up and cool-down exercises: stretching various muscle groups for a duration of 15 to 20 minutes and a slow 3-minute walk 2. Aerobic training: using a lower-limb cycle ergometer for a duration of 30 to 40 minutes. Initiated warm-up at 0 wattages for 5 minutes. Incrementally increased wattages within 5-10 minutes until reaching the 40-80% heart rate reserve or 4 to 6 of modified Borg scale for at least 20 minutes. Concludes with a 5-minute cool-down period at 10 wattages. 3. The resistance training involves both upper and lower limbs: （1） Upper Limb Resistance Training: Shoulder lift, abduction, and horizontal abduction exercises are performed. Each exercise is repeated for three sessions comprising 10 repetitions each. A 0.5-2 kg dumbbell is utilized for resistance. （2） Lower Limb Resistance Training: Sit-to-stand exercises are performed. Each session consists of three sets of 10 repetitions. **Name:** Comprehensive pulmonary rehabilitation programs **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), C reactive protein (CRP), Surfactant Protein-D (SP-D), Granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-1 beta, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12 p70, IL-13, IL-18, tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma **Measure:** inflammation-related and immune-related biomarkers **Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks #### Primary Outcomes **Description:** Six-minute walk test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. **Measure:** Six-minute walk distance (6MWD) **Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks #### Secondary Outcomes **Description:** Using spirometry to measure pulmonary function parameters. **Measure:** Pulmonary function test **Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks **Description:** Measurement of respiratory muscle strength includes maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), which assess the force exerted by muscles during maximal inspiratory and expiratory efforts, respectively. During the test, the subject sits and uses a mouthpiece connected to an electronic pressure gauge while wearing a nose clip to prevent air leakage. For MIP, the subject starts from residual volume and performs a maximal inspiratory effort. For MEP, the subject starts from total lung capacity and performs a maximal expiratory effort. The highest value from three measurements is recorded as the test result. **Measure:** Respiratory muscle strength **Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks **Description:** Length of hospital stay **Measure:** Length of hospital stay (LoS) **Time Frame:** an average of post-surgery 2 weeks **Description:** Duration of chest-tube insertion **Measure:** Duration of chest-tube insertion **Time Frame:** an average of post-surgery 2 weeks **Description:** The Numerical Rating Scale (NRS) is a commonly used clinical tool for assessing pain intensity, ranging from 0 to 10 to represent varying degrees of pain. It is scored from 0-10 (0 meaning no pain and 10 meaning the worst pain. **Measure:** Numerical Rating Scale (NRS) **Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks **Description:** The EORTC QLQ-C30 is designed to assess health-related quality of life in cancer patients, consisting of 30 items. It includes five functional scales: cognitive (2 items), emotional (4 items), physical (5 items), role (2 items), and social (2 items) functions. Symptom scales cover fatigue (3 items), nausea/vomiting (2 items), and pain (2 items). Single items assess appetite loss, constipation, diarrhea, dyspnea, sleep disturbances, and financial difficulties. Additionally, two items evaluate overall health status/quality of life. Each item is equally weighted, with scores linearly transformed to a 0-100 scale. For functional scales and overall health status/quality of life, higher scores indicate better function or quality of life, whereas higher scores on symptom scales denote more severe symptoms or problems. **Measure:** European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30, version 3, Chinese Mandarin (Taiwan)) **Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks **Description:** Postoperative complications (POCs) and postoperative pulmonary complications (PPCs) **Measure:** Postoperative complications (POCs) and postoperative pulmonary complications (PPCs) **Time Frame:** an average of post-surgery 2 weeks **Description:** measured by volume-oriented incentive spirometry **Measure:** Lung expansion volume **Time Frame:** Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults (age ≥ 20 years old) * Receiving lung resection surgery * At least one of the following: 6MWD \< 500 meters, oxygen saturation by pulse oximetry (SpO2) drop ≥ 4% or SpO2\< 90% during 6MWT, pre-operative FEV1 or FVC ≤ 80% of predicted value or FEV1/FVC ratio ≤ 0.7 * Able to walk autonomously without mobility aids * Written informed consent Exclusion Criteria: * Neoadjuvant therapy with chemo- or radiotherapy in the six months prior to surgery * Received pulmonary rehabilitation programs six months prior to surgery * Previous lung resection * Inability to perform the exercise training * Instability in cardiovascular disease, neurological disorders, or musculoskeletal conditions * Have cognitive deficits with potential severe impact on compliance * Do not provide written informed consent **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chun-Jung Chang **Phone:** +886 5 362-1000 **Phone Ext:** 2597 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Chang Gung Memorial Hospital **Name:** Chun-Jung Chang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M8243 - Name: Expectorants - Relevance: LOW - As Found: Unknown - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432621 **Brief Title:** Role of Sugammadex and Neostigmine for Recovery From Rocuronium **Official Title:** Sugammadex Versus Neostigmine for Recovery of Respiratory Muscle Strength Measured by Ultrasonography in the Postextubation Period in Laparoscopic Cholecystectomy #### Organization Study ID Info **ID:** MD201/2023 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-19 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Ahmed wagih Ezzat deusouky **Investigator Title:** lecturer of anasthesia,intensive care and pain management **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** evaluation the reversal of neuromuscular blocking by sugammadex versus neostigmine through assessing the residual neuromuscular blocking effect by ultrasound imaging of expiratory muscle strength and diaphragmatic excursion. **Detailed Description:** All patients will be assessed preoperatively by careful history taking (history of allergy to rocuronium, neostigmine, or sugammadex), full medical history taking , ASA classification and surgical history Premedication with 2mg midazolam. Anesthesia will be induced with propofol 1-2 mg /kg and fentanyl 1-2 mic/kg. After calibration of TOF (train of four) rocuronium 0.6 mg/kg will be administered, and tracheal intubation will be performed in the absence of train-of four (TOF) count. Rocuronium 0.15mg/kg and Sevoflurane will be used for maintenance of anesthesia. At the end of the surgery, patients in group A will receive sugammadex (2 mg/kg) and patients in group B will receive neostigmine (50 μg/kg, maximum 5 mg) combined with atropine (25 μg/kg, maximum 2.5 mg) after TOF counts at least exceeding 1 and extubation will be performed in the operating room when the patient is fully awake and fulfilled clinical criteria for extubation. Diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography. ### Conditions Module **Conditions:** - Anesthesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients who will receive sugammadex for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation. **Intervention Names:** - Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation **Label:** Group S **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** patients who will receive neostigmine for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation. **Intervention Names:** - Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation **Label:** Group N **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group N - Group S **Description:** patients will be randomly divided into two groups using a computer generated random number chart. Group S will receive sugammadex for reversal of rocuronium, whereas Group N will receive neostigmine for reversal of rocuronium using nerve stimulation and ultrasound to asses recovery of respiratory muscle **Name:** using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** complete recovery of skeletal muscle assesed by train of four and diaghragmatic excursion by ultrasuond automatically recorded utilizing the TOF monitoring TFIO and diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography (Sonosite M-Turbo) at 3 predefined time points: before induction (baseline levels), TOFR ≥0.9 (postextubation), and after 30 minutes in the PACU. **Measure:** effect of sugammadex and neostigmine on reversal of rocuronium **Time Frame:** 4 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with American Society of Anesthesiology (ASA) physical status classification I and II Exclusion Criteria: * 1. American Society of Anesthesiology (ASA) physical status classification III-V 2. renal impairment 3. Significant liver disease (Child-Pugh B or C class) 4. History of chronic obstructive pulmonary disease 5. Known or suspected neuromuscular disease. 6. Cardiac arrhythmia or use of antiarrhythmic drugs. **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of Medicine, Ain Shams University ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000003473 - Term: Neuromuscular Nondepolarizing Agents - ID: D000009466 - Term: Neuromuscular Blocking Agents - ID: D000009465 - Term: Neuromuscular Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000002800 - Term: Cholinesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000010277 - Term: Parasympathomimetics - ID: D000001337 - Term: Autonomic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12333 - Name: Neostigmine - Relevance: HIGH - As Found: Head and Neck Cancer - ID: M1666 - Name: Rocuronium - Relevance: HIGH - As Found: Etoposide - ID: M6684 - Name: Neuromuscular Nondepolarizing Agents - Relevance: LOW - As Found: Unknown - ID: M12409 - Name: Neuromuscular Blocking Agents - Relevance: LOW - As Found: Unknown - ID: M6040 - Name: Cholinesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077123 - Term: Rocuronium - ID: D000009388 - Term: Neostigmine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432608 **Acronym:** FC **Brief Title:** Efficacy of Lacticaseibacillus Paracasei Strain Shirota on Clinical Manifestation of Functional Constipation in Mexican Adults **Official Title:** Single Arm Study to Evaluate the Efficacy of Lacticaseibacillus Paracasei Strain Shirota (Formerly Lactobacillus Casei Strain Shirota) Fermented Milk (Yakult®) on the Maintenance of Clinical Manifestations of Functional Constipation in Mexican Adults #### Organization Study ID Info **ID:** UDG-FC-2024 #### Organization **Class:** OTHER **Full Name:** University of Guadalajara ### Status Module #### Completion Date **Date:** 2025-11-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Yakult Honsha Co., LTD #### Lead Sponsor **Class:** OTHER **Name:** University of Guadalajara #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Chronic functional constipation is a gastrointestinal disorder with an approximate prevalence of 14% of the Mexican population, which is characterized by difficult or incomplete defecation and/or infrequent bowel movements, with the absence of symptoms such as abdominal pain or inflammation, and in If they occur, they should not be the predominant symptoms. Its origin is multifactorial and includes variables such as diet, water consumption, alteration in motility, and intestinal microbiota, the latter as a source of different secondary metabolites such as short-chain fatty acids (SCFAs). Lower SCFA values in constipation would alter the relationship between them, increasing the risk of clinical manifestations of functional chronic constipation. In addition to physical discomfort, subjects with this disease manifest alterations in their quality of life. Recent studies have suggested using probiotic microorganisms to treat this functional disorder due to their beneficial effects on evacuation frequency, SCFAs, and quality of life. However, in Mexico, knowledge of the above is limited. Therefore, this research aims to determine the effect of consuming a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota on the clinical manifestations of functional constipation in Mexican adults and its relationship with SCFAs. **Detailed Description:** 1. Background Constipation is an intestinal disorder characterized by difficulty defecating, infrequent bowel movements, hard or lumpy stools, excessive straining, a feeling of incomplete evacuation, and, in some cases, the use of manual techniques to facilitate evacuation. Due to its presentation time, constipation is classified as acute or chronic. The acute one lasts less than a week and is commonly determined by a change in diet and/or lifestyle (low fiber intake, decreased physical activity, stress, going to the bathroom in an unknown place, etc.). For its part, the symptoms of chronic illness have occurred over three to six months. Chronic constipation is among the most common gastrointestinal conditions, usually primary or secondary. The first is a consequence of multiple pathophysiological alterations, such as alteration of colonic regulation, lack of coordination of the neuromuscular apparatus, and dysfunction of the brain-gut axis. In turn, secondary chronic constipation can be caused by drugs, neurological disorders, anatomical processes, or metabolic diseases. Chronic constipation is defined "from a clinical point of view, chronic constipation is considered secondary when it is a consequence of metabolic, neurological alterations, structural lesions or medications. When other causes have been excluded, it is considered primary, idiopathic, or functional constipation" (FD). 1.1. Clinical manifestations Chronic constipation is a functional gastrointestinal disorder with a prevalence of 3 to 27%, mainly among women and older adults. Approximately 1 in 6 individuals experience chronic constipation. The Mexican Consensus on chronic constipation mentions a prevalence of 14.4% in Mexicans, while other studies carried out in the country have reported a prevalence between 2.4 and 22.3%. This pathology is considered a syndrome with different symptoms that are expressed variably. For this reason, the ROMA (Rome Foundation for Functional Gastrointestinal Problems) criteria have been used to diagnose functional chronic constipation. In 2016, the ROMA criteria updated their guidelines, currently in version IV, and included eight categories: A) esophageal disorders; B) gastroduodenal disorders; C) intestinal disorders; D) gastrointestinal pain of centrally median disorders; E) disorders of the sphincter of Oddi and the gallbladder; F) anorectal disorders; G) functional gastrointestinal disorders of childhood and G) functional gastrointestinal disorders of adolescence. Functional intestinal disorders are defined by these criteria, which allow us to differentiate the symptoms of patients with chronic functional constipation from those with similar clinical conditions, such as irritable bowel syndrome. In the ROME IV criteria, chronic functional constipation is a disorder characterized by persistent or incomplete difficult defecation and/or infrequent bowel movements without symptoms such as abdominal pain and/or inflammation or, if present, that are not the predominant symptoms. The Bristol scale supports the criteria in which grades 1 and 2 correspond to constipation and correlate with prolonged intestinal transit. 1.2. Constipation and short-chain fatty acids Chronic constipation is a multifactorial process influenced by diet, stool volume, water content, and intestinal microbiota. In recent years, it has been considered that alterations in the balance of the intestinal microbiota may influence the clinical manifestations of chronic constipation. It has been reported that the intestinal microbiota of constipated patients differs from that of healthy adults and children, with a decrease in the genera Lactobacillus and Bifidobacterium. Studies with gnotobiotic animals and in vitro have suggested that the intestinal microbiota influences intestinal motility, the integrity of the intestinal barrier, the modulation of colonic pH, and the immune or nervous response through the production of short-chain fatty acids: butyrate, propionate, and acetate. 1.3. Constipation and probiotics Patients with constipation usually have a prolonged intestinal transit time compared to healthy subjects, decreasing evacuation frequency and stool consistency. To achieve this, laxatives, dietary fiber supplements, and the prescription of some drugs are used as treatment. However, in recent years, the use of probiotics has been considered due to the impact of their consumption on the intestinal microbiota/metabolites and, in turn, on gastric motility. It has been reported that consuming 10\^8 to 3 x 10\^10 CFU per day of specific probiotic strains improves intestinal transit, increases evacuation frequency, and improves symptoms related to constipation. Studies with Lacticaseibacillus paracasei strain Shirota (LcS) in the Chinese population showed improvement in the frequency and consistency of fecal matter and reduced intestinal discomfort. The intake of probiotics improves intestinal transit and increases the levels of organic acids that promote peristalsis. It also increases the Bifidobacterium and Lactobacillus genera, which are usually in lower abundance in constipation. Probiotics could not only directly improve intestinal discomfort but also through the formation of secondary metabolites of the intestinal microbiota, such as short-chain fatty acids. Therefore, probiotics such as Lacticaseibacillus paracasei strain Shirota have begun to be studied in murine models and in the Asian population as a non-pharmacological alternative for functional chronic constipation. However, its effect on the Mexican population with constipation requires more evidence, as does the relationship between the intake of probiotics in functional constipation and short-chain fatty acids. 2. General objective: To evaluate the efficiency of Lacticaseibacillus paracasei strain Shirota Shirota (formerly Lactobacillus casei strain Shirota) in fermented milk (Yakult®) on the maintenance of the clinical manifestations of functional constipation in Mexican adults. 3. Hypothesis: The consumption of a product based on milk fermented with Lacticaseibacillus paracasei strain Shirota, has an effect on the maintenance of the clinical manifestations of functional constipation in Mexican adults. 4. Methodology: An original longitudinal, analytical, and prospective quasi-experimental study in adults diagnosed with functional chronic constipation under the ROME IV criteria is planned. The study will provide a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota for four weeks. Before consuming the product, a baseline analysis of SCFAs will be carried out in fecal matter. As part of the techniques and procedures, height and weight will be measured using the ISAK methodology to obtain the body mass index (BMI). Meanwhile, the clinical manifestations of evacuation frequency and consistency of fecal matter will be evaluated, considering the ROME IV criteria, with visual support from the Bristol and symptom severity scales. The analysis of short-chain fatty acids will be done by gas chromatography, whose signal will be compared with an internal standard. ### Conditions Module **Conditions:** - Constipation **Keywords:** - functional constipation - clinical manifestation - mexican - short fatty acids - Lacticaseibacillus paracasei strain Shirota ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Original longitudinal, analytical, and prospective quasi-experimental study in adults diagnosed with functional chronic constipation under the ROME IV criteria. The study will provide a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota for 4 weeks. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The single arm contemplates providing the study subjects diagnosed with functional constipation with a product based on fermented milk (80mL) daily for 4 weeks. **Intervention Names:** - Dietary Supplement: fermented milk, Yakult **Label:** Experimental group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** Study subjects will be provided with a product based on fermented milk, Yakult (80mL) daily for four weeks in order to know the effects of clinical manifestation of functional constipation and short-fatty acids in the Mexican population **Name:** fermented milk, Yakult **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Clinical manifestation will be measure by Bristol scale (1-2 hard stools; 3-4 normal; 4-5 soft stools), Frequency of bowel movements will be obtained by the question of how many times per week have defecated, meanwhile severity of symptoms related to constipation will include indicators of difficulty passing stool, pain, and feeling of incomplete evacuation on a 4-point scale (1, none; 2, a little; 3, some; and 4, a lot) **Measure:** Clinical manifestation of functional constipation **Time Frame:** 2 months #### Secondary Outcomes **Description:** The short chain fatty acids acetate, butyrate and propionate will be analyzed from the fecal material sample. Fatty acids will be measured by gas chromatography equipped with a flame ionization detector and a MEGA-ACID (FFAD) chromatographic column of 30.0m length, with internal diameter: 0.25 ID, thickness: 0.40 µm and 3µL injector. Samples will be analyzed by chromatographic method through the MEGA-ACID column, with an injection of 3 µL and whose injection mode is Split 1:25. The column flow will be 3.0 mL/min, in 29 min at 250°C, with a gas flow of N2 30.0mL/min, H2 40mL/min, Air 400 mL/min. The signal ratio (peak area ratio) of the short chain fatty acid compared to internal standards: acetic acid (71251 Sigma-Aldrich), propionic acid (94425 Sigma-Aldrich), butyric acid (19215 Sigma-Aldrich); in a range of 3.13-400ppm. It will later be corrected by the relative correction factor. The above will be used to calculate the concentration of the short chain fatty acid. **Measure:** Analysis of short-chain fatty acids **Time Frame:** 2 months **Description:** Height (mt) it will be recorded which technique extension requires the subject to stand with the feet apart at a 45° angle and the heels together, the posterior aspect of the buttocks and the upper back resting on the stadiometer.The head should be in the Frankfort plane. The subject is asked to take a deep breath and hold it, The scorer places the square triangular piece firmly over the vertex, squeezing the hair as tightly as possible. The measurement is taken at the end of a deep breath. **Measure:** Height **Time Frame:** 2 months **Description:** Body weight (kg) will be checked that the scale is in the zero register. Then the subject stands in the center of it without support and with the weight distributed evenly between both feet. The head should be elevated and the eyes looking directly forward. **Measure:** Body weight **Time Frame:** 2 months **Description:** The body mass index (BMI) will be calculated by dividing the weight, previously obtained from the person evaluated, by the squared height (mt). BMI will be reported in categories: \<18.5, 18.5 - 24.9, 25-29.9 and \>30 **Measure:** Body Mass Index (BMI) **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men and women between 20 and 60 years old, diagnosed with functional chronic constipation (according to the Rome IV criteria). * Men and women who have given informed consent. Exclusion Criteria: * Constipation due to neurological, pharmacological or organic causes. * Pregnancy or pregnancy expected within the next month. * Breastfeeding women. * Diagnosed pathologies such as: diabetes mellitus, kidney or liver failure, infectious disease, inflammatory disease or any neoplastic disease. * Use of laxatives within 14 days prior to the start of the intervention. * Use of antibiotics within 14 days prior to the start of the intervention. * Diagnosis of cancer in the last three years. * History of drug and medication abuse. * Active alcoholism with a daily intake greater than 50 g/day. * Lactose intolerance. * Known allergies to any substance in the study product (e.g., cow's milk proteins). * Any subject who needs manual maneuvers to evacuate feces. * Anticipated major changes in diet or exercise during the study period. * Eating disorders. * Participation in another study with any investigational product within 3 months prior to enrollment. * Regular Yakult consumers * Subject who does not have the capacity to consent. **Maximum Age:** 60 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Angélica Villarruel, PhD **Phone:** 52 (33) 1378 5900 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Guadalajara **Name:** Ma.Refugio Torres Vitela, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** This is a project that involves data about patent **IPD Sharing:** NO ### References Module #### References **Citation:** Aziz I, Whitehead WE, Palsson OS, Tornblom H, Simren M. An approach to the diagnosis and management of Rome IV functional disorders of chronic constipation. Expert Rev Gastroenterol Hepatol. 2020 Jan;14(1):39-46. doi: 10.1080/17474124.2020.1708718. Epub 2020 Jan 2. **PMID:** 31893959 **Citation:** Araujo MM, Botelho PB. Probiotics, prebiotics, and synbiotics in chronic constipation: Outstanding aspects to be considered for the current evidence. Front Nutr. 2022 Dec 8;9:935830. doi: 10.3389/fnut.2022.935830. eCollection 2022. **PMID:** 36570175 **Citation:** Chen S, Ou Y, Zhao L, Li Y, Qiao Z, Hao Y, Ren F. Differential Effects of Lactobacillus casei Strain Shirota on Patients With Constipation Regarding Stool Consistency in China. J Neurogastroenterol Motil. 2019 Jan 31;25(1):148-158. doi: 10.5056/jnm17085. **PMID:** 30646486 **Citation:** Cheng Y, Liu J, Ling Z. Short-chain fatty acids-producing probiotics: A novel source of psychobiotics. Crit Rev Food Sci Nutr. 2022;62(28):7929-7959. doi: 10.1080/10408398.2021.1920884. Epub 2021 May 6. **PMID:** 33955288 **Citation:** Dimidi E, Christodoulides S, Fragkos KC, Scott SM, Whelan K. The effect of probiotics on functional constipation in adults: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2014 Oct;100(4):1075-84. doi: 10.3945/ajcn.114.089151. Epub 2014 Aug 6. **PMID:** 25099542 **Citation:** Forootan M, Bagheri N, Darvishi M. Chronic constipation: A review of literature. Medicine (Baltimore). 2018 May;97(20):e10631. doi: 10.1097/MD.0000000000010631. **PMID:** 29768326 **Citation:** Lange O, Proczko-Stepaniak M, Mika A. Short-Chain Fatty Acids-A Product of the Microbiome and Its Participation in Two-Way Communication on the Microbiome-Host Mammal Line. Curr Obes Rep. 2023 Jun;12(2):108-126. doi: 10.1007/s13679-023-00503-6. Epub 2023 May 19. **PMID:** 37208544 **Citation:** Markowiak-Kopec P, Slizewska K. The Effect of Probiotics on the Production of Short-Chain Fatty Acids by Human Intestinal Microbiome. Nutrients. 2020 Apr 16;12(4):1107. doi: 10.3390/nu12041107. **PMID:** 32316181 **Citation:** Morrison DJ, Preston T. Formation of short chain fatty acids by the gut microbiota and their impact on human metabolism. Gut Microbes. 2016 May 3;7(3):189-200. doi: 10.1080/19490976.2015.1134082. Epub 2016 Mar 10. **PMID:** 26963409 **Citation:** Simren M, Palsson OS, Whitehead WE. Update on Rome IV Criteria for Colorectal Disorders: Implications for Clinical Practice. Curr Gastroenterol Rep. 2017 Apr;19(4):15. doi: 10.1007/s11894-017-0554-0. **PMID:** 28374308 **Citation:** Schmulson Wasserman M, Francisconi C, Olden K, Aguilar Paiz L, Bustos-Fernandez L, Cohen H, Passos MC, Gonzalez-Martinez MA, Iade B, Iantorno G, Ledesma Ginatta C, Lopez-Colombo A, Perez CL, Madrid-Silva AM, Quilici F, Quintero Samudio I, Rodriguez Varon A, Suazo J, Valenzuela J, Zolezzi A. [The Latin-American Consensus on Chronic Constipation]. Gastroenterol Hepatol. 2008 Feb;31(2):59-74. doi: 10.1157/13116072. Spanish. **PMID:** 18279643 **Citation:** Yuan F, Tan W, Ren H, Yan L, Wang Y, Luo H. The Effects of Short-Chain Fatty Acids on Rat Colonic Hypermotility Induced by Water Avoidance Stress. Drug Des Devel Ther. 2020 Nov 2;14:4671-4684. doi: 10.2147/DDDT.S246619. eCollection 2020. **PMID:** 33173277 **Citation:** Zhuang M, Shang W, Ma Q, Strappe P, Zhou Z. Abundance of Probiotics and Butyrate-Production Microbiome Manages Constipation via Short-Chain Fatty Acids Production and Hormones Secretion. Mol Nutr Food Res. 2019 Dec;63(23):e1801187. doi: 10.1002/mnfr.201801187. Epub 2019 Oct 22. **PMID:** 31556210 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M6472 - Name: Constipation - Relevance: HIGH - As Found: Constipation - ID: M15974 - Name: Sprains and Strains - Relevance: HIGH - As Found: Strain - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003248 - Term: Constipation - ID: D000013180 - Term: Sprains and Strains ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T355 - Name: Acidophilus - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432595 **Brief Title:** Effect of Instability Resistance Training on Balance, Core Muscle Strength, and Athletic Performance **Official Title:** Effect of Instability Resistance Training on Balance, Core Muscle Strength, and Athletic Performance Among Young Male Chinese Kayak Canoeists #### Organization Study ID Info **ID:** JKEUPM-2023-256 #### Organization **Class:** OTHER **Full Name:** Universiti Putra Malaysia ### Status Module #### Completion Date **Date:** 2023-09-22 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-22 **Type:** ACTUAL #### Start Date **Date:** 2023-06-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-01-07 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universiti Putra Malaysia #### Responsible Party **Investigator Affiliation:** Universiti Putra Malaysia **Investigator Full Name:** Jianxin Gao **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this experimental study is to examine the effect of instability resistance training (IRT) on balance ability, core muscle strength, and athletic performance of young Chinese male kayak canoeists. The main questions it aims to answer are: Do the IRT and TRT methods have any effect on the subject's balance ability in terms of static balance and dynamic balance? Do the IRT and TRT methods have any effect on the subject's isometric strength of the core muscle group in terms of abdomen, back, left lateral, and right lateral? Do the IRT and TRT methods have any effect on the subject's isotonic strength of the core muscle group in terms of flexion, extension, left lateral flexion, and right lateral flexion? Do the IRT and TRT methods have any effect on the subject's athletic performance in terms of dynamometer performance and calm-water performance? Researchers will compare the effect of instability resistance training (IRT) and traditional resistance training (TRT) on balance ability, core muscle strength, and athletic performance of young Chinese male kayak canoeists. Participants will: Take 12-week instability resistance training (IRT) and traditional resistance training (TRT) difficulty level (primary level 1-4 weeks, intermediate level 5-8 weeks, and advanced-level 9-12 weeks). Take 3 training sessions per week and complete the training on Mondays, Wednesdays, and Fridays from 4 to 5 pm. **Detailed Description:** This study aimed to investigate the effect of a 12-week IRT on balance, core strength, and athletic performance among young male Chinese kayak canoeists. A Cluster Randomized Controlled Trial (CRCT) study was conducted. Firstly, the 2 city-level representative teams were chosen from 4 city-level representative teams of Jiangxi province and randomly assigned as two groups (experimental group and control group) using the Lottery Method. Secondly, 64 eligible kayak canoeists between the ages of 16-22 years (19.10±1.38) were recruited from the selected 2 city-level representative teams and randomly assigned to the instability resistance training (IRT) for the experimental group and traditional resistance training (TRT) for the control group using the same Lottery Method. The intervention was divided into 3 levels (primary, intermediate, and advanced) for IRT and TRT. Both groups performed training for 60 minutes, three times a week. The Swiss ball, BOSU ball, and Wobble boards were only provided with unstable surfaces for the IRT group. The intensity was body weight for both training methods. Dependent variables involving balance, core muscle strength, and athletic performance were measured using Flamingo Balance Test (FBT), Star Excursion Balance Test (SEBT), Abdomen Bridge (AB), Back Bridge (BB), Left and Right Lateral Bridge (LLB and RLB), 1min Sit-Up (SU), 1min Back Hyperextension (BH), 1min Left and Right Lateral V-up (LLV and RLV), K-1 200m Dynamometer Performance (DP), and Men's K-1 200m Calm-Water Performance (CWP) tests respectively in pre-test, post-test 1 (week 6), post-test 2 (week 12). ### Conditions Module **Conditions:** - Athletic Performance **Keywords:** - Instability resistance training - Balance ability - Core muscle strength - Athletic performance - Kayak canoeists ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After pre-testing, participants were randomly assigned to two groups. The participants of the IRT group were conducted in a 12-week (July 3 to September 22, 2023) Instability resistance training program that was performed one hour and three times per week (Mondays, Wednesdays, and Fridays from 4 to 5 pm) in the Nanchang Yao Lake base. **Intervention Names:** - Other: Instability resistance training and Traditional resistance training **Label:** Instability resistance training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** After pre-testing, participants were randomly assigned to two groups. The participants of the TRT group were conducted in a 12-week (July 3 to September 22, 2023) traditional resistance training program that was performed one hour and three times per week (Mondays, Wednesdays, and Fridays from 4 to 5 pm) in the Ganzhou Shangyou base. **Intervention Names:** - Other: Instability resistance training and Traditional resistance training **Label:** Traditional resistance training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Instability resistance training - Traditional resistance training **Description:** The 20 intervention actions were divided into three levels (primary, intermediate, and advanced) for instability resistance training and traditional resistance training. Both groups performed training for 60 minutes three times a week. The Swiss ball, BOSU ball, and Wobble boards only provided an unstable surface environment for instability resistance training. The intensity/load was body weight for both training methods. **Name:** Instability resistance training and Traditional resistance training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Flamingo Balance Test **Measure:** Static Balance **Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention) **Description:** Star Excursion Balance Test **Measure:** Dynamic Balance **Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention) **Description:** Abdomen Bridge **Measure:** Abdomen Core Strength **Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention) **Description:** Back Bridge **Measure:** Back Core Strength **Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention) **Description:** Left Lateral Bridge **Measure:** Left Lateral Core Strength **Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention) **Description:** Right Lateral Bridge **Measure:** Right Lateral Core Strength **Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention) **Description:** Men's K-1 200m Dynamometer Performance **Measure:** Dynamometer Performance **Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention) **Description:** Men's K-1 200m Calm-Water Performance **Measure:** Calm-Water Performance **Time Frame:** This study collected data in pre-test (before intervention), post-test 1 (6 weeks after intervention), and post-test 2 (12 weeks after intervention) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Male, Aged 16-22, and Healthy Exclusion Criteria: Athletes who are systematically training their balance ability and core muscle strength **Healthy Volunteers:** True **Maximum Age:** 22 Years **Minimum Age:** 16 Years **Sex:** MALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Serdang **Country:** Malaysia **Facility:** Jianxin Gao **State:** Selangor **Zip:** 43400 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432582 **Brief Title:** hepatomiR cACLD Study **Official Title:** Assessment of a hepatomiR Cut-off for Predicting Specific Hepatic Decompensation Events in Advanced Chronic Liver Disease #### Organization Study ID Info **ID:** UKStP_hepatomiR_cACLD #### Organization **Class:** OTHER **Full Name:** Karl Landsteiner University of Health Sciences ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** University Hospital St. Pölten #### Lead Sponsor **Class:** OTHER **Name:** Karl Landsteiner University of Health Sciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study looks to gather data on hepatomiR, a CE-certified test already intended for gauging liver-related outcomes, in order to define a cut-off regarding specific decompensation events (ascites, variceal hemorrhage, hepatic encephalopathy) in chronic liver disease (CLD). Based on these data, it is aimed to advance the current understanding of factors driving decompensation, with potential repercussions for future risk management and therapy. ### Conditions Module **Conditions:** - Chronic Liver Disease and Cirrhosis - Chronic Liver Disease - Portal Hypertension **Keywords:** - hepatomiR - micro-RNA - hepatic decompensation - ACLD ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 156 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with compensated advanced chronic liver disease (cACLD) regardless of etiology **Intervention Names:** - Diagnostic Test: hepatomiR **Label:** cACLD ### Interventions #### Intervention 1 **Arm Group Labels:** - cACLD **Description:** hepatomiR is a CE-certified test intended for gauging liver-related outcomes. It quantifies the levels of hsa-miR-122-5p, hsa-miR-192-5p, and hsa-miR-151a-5p in human plasma samples. A proprietary algorithm is then used to compute a liver function score (hepatomiR p-score). **Name:** hepatomiR **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy) **Measure:** Occurrence of any hepatic decompensation event (per patient) **Time Frame:** 12 months #### Secondary Outcomes **Measure:** Number and type of individual decompensation events (per patient) **Time Frame:** 12 months **Measure:** Number of hospital admissions (per patient) **Time Frame:** 12 months **Description:** EF-CLIF (European Association for the Study of the Liver - Chronic Liver Failure) definition, CLIF-C (chronic liver failure score) ACLF (acute on chronic liver failure) grading **Measure:** Number of acute on chronic liver failure events (per patient) **Time Frame:** 12 months **Measure:** Number of ICU (intensive care unit) admissions (per patient) **Time Frame:** 12 months **Measure:** Development of hepatocellular cancer or cholangiocarcinoma (per patient) **Time Frame:** 12 months **Measure:** Number of deaths **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years * Chronic liver disease (more than 6 months) * LSM ≥ 10 kPa * Outpatient at the Clinical Department of Internal Medicine II, University Hospital St. Pölten * Signed patient consent form Exclusion Criteria: * Age older than 18 years * Pregnancy * Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population is made up of patients with compensated advanced chronic liver disease (cACLD) regardless of etiology; cACLD will be defined as per the Baveno VII consensus (LSM values: ≥ 10 kPa ACLD, less than 10 kPa non-ACLD). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lukas Erhart, Mag. Dr. **Phone:** 00432742900412311 **Role:** CONTACT #### Locations **Location 1:** **City:** St. Pölten **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lukas Erhart, Mag. Dr. - **Role:** CONTACT **Country:** Austria **Facility:** University Hospital St. Pölten **State:** Lower Austria **Status:** RECRUITING **Zip:** 3100 #### Overall Officials **Official 1:** **Affiliation:** Karl Landsteiner University of Health Sciences **Name:** Andreas Maieron, PD Dr. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M11103 - Name: Liver Cirrhosis - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: HIGH - As Found: Liver Disease - ID: M10026 - Name: Hypertension, Portal - Relevance: HIGH - As Found: Portal Hypertension - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000008107 - Term: Liver Diseases - ID: D000006975 - Term: Hypertension, Portal ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M9662 - Name: Altretamine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432569 **Acronym:** B/P3_1 **Brief Title:** Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1) **Official Title:** Evaluation of Butyrate and Palmitoylethanolamide Effects on Intestinal Permeability and Microbiota Gut Composition in Patients With Irritable Bowel Syndrome - A Double-blind, Placebo-controlled Crossover Randomized Study #### Organization Study ID Info **ID:** 5475-AO-22 #### Organization **Class:** OTHER **Full Name:** University of Padova ### Status Module #### Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-03-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-08 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2023-02-27 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Padova #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Evaluation of the effects of butyrate ( BitirBioma) and palmitoylethanolamide( PEA=PeaBioma) on intestinal permeability and gut microbiota composition in patients with irritable bowel syndrome. Study B/P 3_1 is an interventional study involving the use of food supplements on the market (BitirBioma Plus and PeaBioma Plus), single-center, double-blind, placebo-controlled, crossover, randomized, in n=50 patients with bowel syndrome irritable, diarrheal and mixed variant (IBS-D and IBS-M), lasting for one year. The study has two arms: Group 1: n=25 Treatment A e Group 2: n=25 Treatment B (with - Treatment A: 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 - Treatment B: Placebo (3+3/day capsules of starch). Eligible subjects with IBS will be randomized in a 1:1 ratio to treatment A or treatment B for six weeks. After the first treatment period, there is a 14-day washout period. Hence, individuals will be treated with B/A treatment for additional six weeks, according to the crossover design. In the two treatment periods, subjects will be required to complete a visual analogue score VAS questionnaire to assess gastrointestinal symptoms and Stool Bristol Scales. During the visit, the subjects will have to record Questionnaire Rome IV to evaluate their quality of life. At the same time, it will be theirs required to provide: * fecal sample for the evaluation of the composition of fecal microbiota (Biomaplan Kit) * a urine sample for the evaluation of intestinal permeability (Gastropack) a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG ) * a capillary blood sample and a serum sample for the detection of Zonulin (Kit Healthy gut and Immundiagnostik AG ) **Detailed Description:** Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon, characterized by relapsing and remitting mucosal inflammation. It presents with symptoms like bloody diarrhea, rectal urgency, fatigue, and abdominal pain. While various therapies are available for managing UC, including medications like amino salicylates, corticosteroids, immunomodulators, and biologics, there's ongoing research into supportive treatments like probiotics. Probiotics are beneficial microorganisms that can positively influence gut health by modifying the gut microbiota, improving intestinal barrier function, and balancing immune response. Several studies have investigated their efficacy in UC management. Notably, the probiotic mixture VSL#3, containing strains of Lactobacillus and Bifidobacteria, has shown promising results in inducing remission in UC patients. Other probiotic products like E. coli Nissle 1917, L. rhamnosus GG, and L. casei DG have also demonstrated effectiveness in maintaining disease remission or prolonging relapse-free periods in UC patients. The product Prolife 10 FORTE, containing multiple strains of Lactobacillus, Bifidobacteria, and Bacillus coagulans, along with prebiotic components and vitamins, has shown potential in positively influencing gut microbiota composition and metabolic activity in healthy individuals. Based on these promising findings, further investigation is warranted to evaluate the potential of Prolife 10 FORTE in improving the gut microbiota composition of UC patients during the remission phase. ### Conditions Module **Conditions:** - Irritable Bowel Syndrome With Diarrhea ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** The study has two arms: Group 1: n=25 Treatment A e Group 2: n=25 Treatment B (with - Treatment A: 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 - Treatment B: Placebo (3+3/day capsules of starch). Eligible subjects with IBS will be randomized in a 1:1 ratio to the treatment A or treatment B for six weeks. After the first treatment period, there is a 14-day washout period. Hence, individuals will be treated with B/A treatment for additional six weeks, according to the crossover design. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Double-blind **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Treatment : 3 capsules/day of butyrate (625 mg) + 3 capsules/day PEA (200 mg) at a ratio of dosage of 3/1 **Intervention Names:** - Dietary Supplement: ButirBioma + PeaBioma **Label:** ButirBioma+PeaBioma **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Treatment Placebo :(3+3/day capsules of starch). **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - ButirBioma+PeaBioma **Description:** randomized in a 1:1 ratio to treatment Butir+Pea or treatment with Placebo for six weeks. After the first treatment period, there is a 14-day washout period. **Name:** ButirBioma + PeaBioma **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo( 3+3 cps/die) **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Collection of faecal sample for the assessment of the faecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit which is used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq , in order to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment. **Measure:** Evaluation of the variation of gut microbiota composition (Microbiota test ) **Time Frame:** 9 months #### Secondary Outcomes **Description:** 1. Analysis of mannitol( normal range 15-25%), lactulose( n.r. 0,45%-0,75%), sucrose(normal \< 0,15%) and sucralose( normal\<1,5%); L/M (normal \<0.03%; borderline 0,03%-0,09%; \>0.09 severe): 2. a capillary blood sample for the detection of Zonulin (Healthy gut Kit) )/Immundiagnostik AG )( normal cut-off 6-10 ng/mL) **Measure:** Evaluation of intestinal permeability(4 sugar test: Gastropack) **Time Frame:** 12 months **Description:** Every evening during the two treatment periods, subjects must record a VAS(Visual Analogue Scale : 1-10; 1= non pain; 10= worst pain possible) questionnaire to assess gastrointestinal symptoms and the Stool Bristol Scale.( 1-7; normal 3-4) **Measure:** Evaluation of Gastrointestinal symptoms( questionary) **Time Frame:** 4 months **Description:** At the visit time points, subjects will have to record the IBS-SSS score( points 75-174 mild, 175-300 moderate; \>300 severe) **Measure:** Evaluation of Quality of Life (IBS-SSS score) (questionary) **Time Frame:** 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ● IBS patients (both males and females) with positive diagnosis based on Rome IV criteria (IBS-D and IBS-M) * Age in the range 18-70 years * Subjects capable of conforming to the study protocol * Subjects who have given their free and informed consent Exclusion Criteria: -Any relevant organic, systemic or metabolic disease, including celiac disease, IDDM (Insulin- Dependant Diabetes Mellitus), Insulin-Independent Diabetes Mellitus, metabolic syndrome, pelvic organ prolapses, urinary incontinence, ulcerative colitis, Crohn's disease, microscopic colitis, infectious colitis, ischemic colitis, complicated diverticular disease. * Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food * Prior major gastrointestinal surgeries * Females of childbearing potential, in the absence of effective contraceptive methods * Subjects who become unable to conform to protocol * Subjects who are continuously taking contact laxatives * Subjects who are treated continuously with glucocorticoids, anti-histaminergic and mast cell stabilizer drugs * Subjects who are treated continuously with trimebutine * Recent history or suspicion of alcohol abuse or drug addiction * Subjects who are treated with antibiotics or probiotics **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Padua **Country:** Italy **Facility:** Edoardo Vinvenzo Savarino **Zip:** 35128 #### Overall Officials **Official 1:** **Affiliation:** University of Padova **Name:** Edoardo Savarino, Prof,MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000003109 - Term: Colonic Diseases, Functional - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000012817 - Term: Signs and Symptoms, Digestive ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M25118 - Name: Irritable Bowel Syndrome - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: M7159 - Name: Diarrhea - Relevance: HIGH - As Found: Diarrhea - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M6337 - Name: Colonic Diseases, Functional - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000043183 - Term: Irritable Bowel Syndrome - ID: D000013577 - Term: Syndrome - ID: D000003967 - Term: Diarrhea ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M340341 - Name: Palmidrol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432556 **Acronym:** MastCellHet **Brief Title:** Study of Cellular Heterogeneity in Patients With Mastocytosis **Official Title:** Study of Cellular Heterogeneity in Patients With Mastocytosis (MastCellHet) Mastocytosis Cell Heterogeneity #### Organization Study ID Info **ID:** RC31/23/0362 #### Organization **Class:** OTHER **Full Name:** University Hospital, Toulouse #### Secondary ID Infos **Domain:** ID-RCB **ID:** 2024-A00021-46 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-06-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Toulouse #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will aim to study the heterogeneity of skin-resident mast cells and of blood circulating hematopoietic progenitors in patients suffering from isolated Cutaneous Mastocytosis and from systemic Mastocytosis with skin lesions. **Detailed Description:** Mastocytosis is a rare disease caused by abnormal mast cell accumulation/proliferation. Its clinical features are very heterogeneous. Among adult patients, 15% present an isolated cutaneous mastocytosis (CM), while 85% of them present a systemic mastocytosis (SM) with cutaneous lesions. In addition, regardless of the diagnosis (i.e., CM or SM), it is frequent to observe mast cell-dependent symptoms of variable severity, ranging from gastrointestinal discomfort to life-threatening reactions. To date, the origin of such heterogeneous manifestations in adult patients is still elusive. Researchers hypothesize that the heterogeneity in mastocytosis symptoms might originate, at least in part, from a broad diversity of mast cell populations in patients. This study will aim to uncover heterogeneity of skin-resident mast cells and of blood circulating hematopoietic progenitors in patients suffering from isolated CM or SM with skin lesions. Patients with isolated CM and patients with SM with cutaneous involvement will be recruited from the Mastocytosis Expert Center of Toulouse. Cluster of Differentiation (CD) 45+ cells from skin biopsies and CD 34+ cells from blood will be isolated by magnetic cell sorting for scRNAseq. Bioinformatics analysis pipeline will be used in order to analyze the cellular heterogeneity of skin lesions and blood from CM and SM patients by comparing their transcriptomic signatures. Using trajectories analysis, the researchers will then deduce infer a differentiation pathway between blood progenitors and cutaneous mast cells at the patient level. Researchers will then confirm the expression of identified relevant biomarkers by highly multiplexed imaging in frozen skin biopsies from CM patients and from SM patients. ### Conditions Module **Conditions:** - Mastocytosis **Keywords:** - Mastocytosis - Mast cells - Cellular heterogeneity - CD 45+ - CD 34+ ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 26 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Genetic: scRNAseq - Procedure: two Skin biopsies **Label:** patients with isolated cutaneous mastocytosis with associated skin involvement - RNAseq **Type:** OTHER #### Arm Group 2 **Intervention Names:** - Procedure: one Skin biopsies **Label:** patients with mastocytosis indolent systemic with associated skin involvement **Type:** OTHER #### Arm Group 3 **Intervention Names:** - Procedure: one Skin biopsies **Label:** patients with isolated cutaneous mastocytosis with associated skin involvement **Type:** OTHER #### Arm Group 4 **Intervention Names:** - Genetic: scRNAseq - Procedure: two Skin biopsies **Label:** patients with mastocytosis indolent systemic with associated skin involvement - RNAseq **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - patients with isolated cutaneous mastocytosis with associated skin involvement - RNAseq - patients with mastocytosis indolent systemic with associated skin involvement - RNAseq **Description:** A blood test tube (only for scRNAseq, 2 tubes of 10 ml per patient) **Name:** scRNAseq **Type:** GENETIC #### Intervention 2 **Arm Group Labels:** - patients with isolated cutaneous mastocytosis with associated skin involvement - RNAseq - patients with mastocytosis indolent systemic with associated skin involvement - RNAseq **Description:** 2 skin biopsies from a lesional area **Name:** two Skin biopsies **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - patients with isolated cutaneous mastocytosis with associated skin involvement - patients with mastocytosis indolent systemic with associated skin involvement **Description:** 1 skin biopsies from a lesional area **Name:** one Skin biopsies **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** through advanced imaging techniques (multiplexed imaging), marker in patients with isolated cutaneous mastocytosis and systemic mastocytosis will be identified compared with control sample **Measure:** marker **Time Frame:** 24 month and one week **Description:** through advanced imaging techniques (multiplexed imaging), marker in patients with isolated cutaneous mastocytosis will be identified compared with control sample **Measure:** marker - isolated cutaneous mastocytosis **Time Frame:** 24 month and one week **Description:** through advanced imaging techniques (multiplexed imaging), marker in patients with systemic mastocytosis will be identified compared with control sample **Measure:** marker - systemic mastocytosis **Time Frame:** 24 month and one week #### Primary Outcomes **Description:** This study aims to examine the diversity of CD 45+ cells in the skin and CD 34+ cells in the circulating blood in patients. The approach used will be single cell sequencing (scRNAseq) to identify the transcriptomic profiles of the different cell populations in these two types of mastocytosis. **Measure:** Study of the diversity of skin CD 45+ cells and circulating blood CD 34+ cells **Time Frame:** 24 month and one week #### Secondary Outcomes **Description:** This part of the study will focus on analyzing common or differential genetic transcripts between patients with isolated cutaneous mastocytosis and those with systemic mastocytosis. The aim is to understand the underlying molecular differences between these two forms of the disease. **Measure:** Study of common or differential transcripts **Time Frame:** 24 month and one week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Criteria related to the study population: * Subject affiliated with a social security or insurance scheme * Subject who has given written consent to his participation in the study * Criteria related to the studied pathology: * Subject diagnosed with isolated cutaneous or indolent systemic mastocytosis with associated skin involvement defined according to World Health Organization criteria (and/or international criteria for cutaneous mastocytosis) * Subjects whose KIT mutation status is known in the skin, bone marrow, and blood Exclusion Criteria: * Criteria related to the study population: * Sun exposure of the biopsied areas expected within the 4 weeks preceding * Subjects who have had exposure to sunlight or artificial UV radiation within the 2 weeks preceding inclusion at the biopsied areas * Adult patients under legal protection, guardianship, or curatorship * Pregnant or lactating women * Criteria related to the studied pathology: * Subjects with an advanced version of the pathology or advanced systemic mastocytosis (SAMA) * Subjects with a known history of allergy or intolerance to local anesthetics * Subjects who have previously shown abnormalities in skin healing or any other contraindication to skin biopsy * Subjects with recognized addiction to alcoholism or drug abuse * Subjects with a hereditary or acquired disorder of hemostasis * Subjects with a severe or acute chronic condition judged by the investigator as incompatible with the trial * Subjects presenting a clinically incompatible immune deficiency with the study * Patients without a well-established diagnosis of mastocytosis * Patients included in a therapeutic study for indolent systemic mastocytosis * Treatment-related criteria: * Any topical or systemic treatment for atopic dermatitis (including phototherapy) ongoing or stopped at least 14 days before the inclusion visit * Systemic corticosteroids within the 4 weeks preceding the inclusion visit * Ongoing systemic treatment likely to interfere with the healing process * Subjects who have undergone physical treatment (radiotherapy, etc.) on the biopsy area in the past 6 months * History of treatment or concomitant treatment that may interfere with the conduct of the study as determined by the investigator **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cristina Bulai Livideanu, MD **Phone:** 0567778138 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Toulouse **Country:** France **Facility:** University Hospital **Zip:** 31059 #### Overall Officials **Official 1:** **Affiliation:** Toulouse univiversity hospital **Name:** Cristina Bulai Livideanu, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009372 - Term: Neoplasms, Connective Tissue - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000090362 - Term: Mast Cell Activation Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11399 - Name: Mastocytosis - Relevance: HIGH - As Found: Mastocytosis - ID: M12317 - Name: Neoplasms, Connective Tissue - Relevance: LOW - As Found: Unknown - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M2776 - Name: Mast Cell Activation Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3626 - Name: Mastocytosis - Relevance: HIGH - As Found: Mastocytosis ### Condition Browse Module - Meshes - ID: D000008415 - Term: Mastocytosis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432543 **Brief Title:** Polyethylene Wear Particle Analysis of THA **Official Title:** Polyethylene Wear Particle Analysis of Total Hip Arthroplasty -International Multicenter Study- #### Organization Study ID Info **ID:** OMU 2023-132 #### Organization **Class:** OTHER **Full Name:** Osaka Metropolitan University ### Status Module #### Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Mayo Clinic **Class:** OTHER **Name:** Hospital for Special Surgery, New York **Class:** OTHER **Name:** Istituto Ortopedico Rizzoli #### Lead Sponsor **Class:** OTHER **Name:** Osaka Metropolitan University #### Responsible Party **Investigator Affiliation:** Osaka Metropolitan University **Investigator Full Name:** Yukihide Minoda **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Purpose of research The purpose of this study was to demonstrate that polyethylene (Vitamin E-containing polyethylene), a newly introduced biomaterial for tibial inserts in hip replacement surgery and widely used clinically, but whose mid- to long-term clinical results are still unknown, is superior to conventional polyethylene in vivo. The aim of this project is to conduct an international multi-center joint research study to determine whether polyethylene wear debris production can be reduced in the future, using an in vivo polyethylene wear debris analysis method that the investigators developed as a method that can provide early feedback. **Detailed Description:** Research method In this study, the investigators conducted the following steps to determine the in vivo wear particles (number, size, and morphology) of conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose mid- to long-term results have not yet been clarified. Clarifying the difference. Target of this research In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment. First total joint replacement * 30 patients using polyethylene containing Vitamin E * 30 patients using conventional polyethylene (no high cross-linking) * 30 patients using conventional polyethylene (with high cross-linking) Accumulation of periarticular tissue In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment. The test will be conducted after obtaining approval from the ethics committee at each facility and obtaining informed consent. The pericapsular tissue, which is removed during surgery and usually discarded, is obtained and fixed in formalin fixative. The tissue will be transported to the Department of Orthopedic Surgery, Osaka Public University Graduate School of Medicine for analysis. International transportation of tissues requires outsourcing to specialized companies with experience in transporting tissues from overseas. Isolation of polyethylene wear debris The collected tissue around the joint capsule is immersed in 5Mol sodium hydroxide at 65°C for 1 hour to decompose the protein. Make a sucrose layer (5, 10, 20%) in a 14ml tube (14PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the dissolved solution, and place in an ultracentrifuge (CP100a, P28S1014 rotor, Hitachi Koki). Ultracentrifuge at 28,000 rpm \[103,7009g\] for 3 hours at 4°C. Prepare an isopropanol layer (0.90 and 0.96 g/mL) in a 40 ml tube (40PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the upper layer of sucrose layer, and centrifuge at 28,000 rpm (103,7009 g) and perform ultracentrifugation at 4°C for 1 hour. The isopropanol interlayer is collected to isolate polyethylene wear debris. Analysis of polyethylene wear debris The isopropanol interlayer is filtered through a 0.1 μm polycarbonate filter (VCTP 013-00, Millipore Corporation, Bedford, MA). Dry the polycarbonate filter, fix it on an aluminum pedestal (M4, Nisshin EM Co, Ltd, Tokyo, Japan), and apply platinum coating (E-1030 ion sputter, Hitachi Science Systems Ltd, Tokyo, Japan). Observe the polyethylene wear particles on the polycarbonate filter using a scanning electron microscope (S4700SI, Hitachi Ltd, Tokyo, Japan), and analyze the following items using an image analyzer (Mac Scope, Mitani Co, Tokyo, Japan). * Number of polyethylene wear particles (number per 1g of tissue) * Size (Equivalent circle diameter \[μm\]) * Shape (aspect ratio, roundness) Comparison of iv vivo polyethylene wear powder morphology depending on polyethylene material The number, size, and form of polyethylene wear debris will be compared between conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose medium- to long-term results have not yet been clarified. The investigators also investigated factors that affect polyethylene wear in vivo (age, height, weight, period from initial surgery to revision surgery, hip joint range of motion, hip prosthesis clinical score \[Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement \[HOOS Jr\], Harris Hip Score, University of California Los Angeles \[UCLA\] activity score\]). ### Conditions Module **Conditions:** - Wear of Articular Bearing Surface of Prosthetic Joint - Hip Arthropathy **Keywords:** - Polyethylene wear particle - Total hip arthroplasty ### Design Module #### Bio Spec **Description:** The pericapsular tissue, which is removed during surgery **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** polyethylene containing Vitamin E **Intervention Names:** - Device: polyethylene **Label:** polyethylene containing Vitamin E #### Arm Group 2 **Description:** conventional polyethylene (no highly cross-linking) **Intervention Names:** - Device: polyethylene **Label:** conventional polyethylene (no highly cross-linking) #### Arm Group 3 **Description:** conventional polyethylene (with highly cross-linking) **Intervention Names:** - Device: polyethylene **Label:** conventional polyethylene (with highly cross-linking) ### Interventions #### Intervention 1 **Arm Group Labels:** - conventional polyethylene (no highly cross-linking) - conventional polyethylene (with highly cross-linking) - polyethylene containing Vitamin E **Description:** No intervention as this is an observational study **Name:** polyethylene **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** counts / g (tissue sample) **Measure:** Number of polyethylene wear particles **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** equivalent circle diameter \[㎛\] **Measure:** Equivalent circle diameter of polyethylene wear particles **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** aspect ratio **Measure:** Aspect ratio of polyethylene wear particles **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** roundness **Measure:** Roundness of polyethylene wear particles **Time Frame:** When tissue sample was collected during THA revision surgery #### Secondary Outcomes **Description:** kg/m2 **Measure:** Body mass index **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** Degrees **Measure:** Hip joint flexion angle **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** Degrees **Measure:** Hip joint exertion angle **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** Degrees **Measure:** Hip joint adduction angle **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** Degrees **Measure:** Hip joint abduction angle **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** 0(worse)-100(best) **Measure:** Hip dysfunction and Osteoarthritis Outcome. Score for Joint Replacement **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** 0(worse)-100(best) **Measure:** Harris Hip Score **Time Frame:** When tissue sample was collected during THA revision surgery **Description:** １(worse)-10(best) **Measure:** University of California at Los Angeles activity score **Time Frame:** When tissue sample was collected during THA revision surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients undergoing revision hip arthroplasty within the study period 2. Patients over 20 years old 3. Patients who have received a sufficient explanation, have sufficient understanding, and have given their free written consent. 4. Patients who have passed 2 years or more since their first total hip arthroplasty Exclusion Criteria: 1. Patients who are judged to be unsuitable as research subjects by the research physician **Minimum Age:** 20 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients undergoing revision hip arthroplasty within the study period ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yukihide Minoda, MD, PhD **Phone:** 81-6-6645-3851 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Osaka Metropolitan University **Name:** Yukihide Minoda, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Iwakiri K, Iwaki H, Kobayashi A, Minoda Y, Kagiyama H, Kadoya Y, Takaoka K. Characteristics of Hylamer polyethylene particles isolated from peri-prosthetic tissues of failed cemented total hip arthroplasties. J Biomed Mater Res B Appl Biomater. 2008 Apr;85(1):125-9. doi: 10.1002/jbm.b.30924. **PMID:** 17806109 **Citation:** Hata K, Minoda Y, Ikebuchi M, Mizokawa S, Ohta Y, Miyazaki N, Miyake Y, Nakamura H. In vivo wear particles of remelted highly crosslinked polyethylene after total hip arthroplasty: report of four cases. J Mater Sci Mater Med. 2015 Mar;26(3):133. doi: 10.1007/s10856-015-5472-9. Epub 2015 Feb 25. **PMID:** 25712074 **Citation:** Minoda Y, Kobayashi A, Sakawa A, Aihara M, Tada K, Sugama R, Iwakiri K, Ohashi H, Takaoka K. Wear particle analysis of highly crosslinked polyethylene isolated from a failed total hip arthroplasty. J Biomed Mater Res B Appl Biomater. 2008 Aug;86(2):501-5. doi: 10.1002/jbm.b.31048. **PMID:** 18360879 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10621 - Name: Joint Diseases - Relevance: HIGH - As Found: Arthropathy - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007592 - Term: Joint Diseases ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M22972 - Name: Tocopherols - Relevance: LOW - As Found: Unknown - ID: M17553 - Name: Vitamin E - Relevance: LOW - As Found: Unknown - ID: M22975 - Name: Tocotrienols - Relevance: LOW - As Found: Unknown - ID: M22969 - Name: alpha-Tocopherol - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: T466 - Name: Tocopherol - Relevance: LOW - As Found: Unknown - ID: T467 - Name: Tocotrienol - Relevance: LOW - As Found: Unknown - ID: T480 - Name: Vitamin E - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432530 **Brief Title:** Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis **Official Title:** Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis #### Organization Study ID Info **ID:** University of Van Yüzüncü Yıl #### Organization **Class:** OTHER **Full Name:** Yuzuncu Yıl University ### Status Module #### Completion Date **Date:** 2024-03-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-15 **Type:** ACTUAL #### Start Date **Date:** 2023-01-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yuzuncu Yıl University #### Responsible Party **Investigator Affiliation:** Yuzuncu Yıl University **Investigator Full Name:** Volkan Şah **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Hematological inflammatory indices (Table 2) are currently very popular and have diagnostic, prognostic, and predictive, roles in various diseases. Considering their promising roles, we hypothesized that hematological inflammatory indices may have a distinctive value between brucella spondylodiscitis and type 1 Modic Changes (MCs). If the hypothesis is valid, early diagnosis-differential diagnosis-treatment processes may become easier and more successful. Given that hematological inflammatory indices are faster, practical, simpler, inexpensive, and easily accessible indicators, they may be more appropriate tools in differentiation between brucella spondylodiscitis and type 1 MCs. **Detailed Description:** This is a retrospective comparative study focusing to distinguish between brucella spondylodiscitis and type 1 MCs considering hematological inflammatory indexes. Patients' data were obtained from Hospital Information Systems, between 2020 to 2024. A total of 35 patients with brucella spondylodiscitis and 37 type 1 MCs were enrolled in the study. Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR, MLR, PLR, NLPR, SII, SIRI, AISI) were derived from baseline CBC tests. Based on the diagnostic tools and criteria1,2,14,21, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar MRI, Complete Blood Count (CBC) test, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) results, and aged 18-65 years were selected to yield a study population. On the other hand, cases with inadequate data, aged \<18 or \>64 years, other infectious spondylodiscitis types than brucella, other MCs types than type 1, and other non-infectious conditions such as rheumatic spondylodiscitis (ankylosing spondylitis or Andersson lesion) were excluded from the study. Also, previous or recurrent brucella spondylodiscitis, involved other spinal levels than the lumbar spine were exclusion causes. The two groups were statistically assessed and compared for baseline features such as age, gender, symptom duration, CRP, ESR, CBC values, and indexes derived from the CBC. ### Conditions Module **Conditions:** - Brucella Spondylitis ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 72 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Based on the diagnostic tools and criteria, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and Erythrocyte Sedimentation Rate (ESR) results, and aged 18-65 years were selected to yield a study population **Intervention Names:** - Other: C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete Blood Count (CBC) values, and indexes derived from the CBC. **Label:** 37 patients with type 1 Modic Changes (MCs) #### Arm Group 2 **Description:** Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnostic tools. Based on the diagnostic tools and criteria, cases diagnosed with lumbar brucella spondylodiscitis or lumbar type 1 MCs in the past 5 years and who had simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and Erythrocyte Sedimentation Rate (ESR) results, and aged 18-65 years were selected to yield a study population **Intervention Names:** - Other: C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete Blood Count (CBC) values, and indexes derived from the CBC. **Label:** 35 patients with brucella spondylodiscitis ### Interventions #### Intervention 1 **Arm Group Labels:** - 35 patients with brucella spondylodiscitis - 37 patients with type 1 Modic Changes (MCs) **Description:** Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR: neutrophil/lymphocyte; MLR: monocyte/lymphocyte; PLR: platelet/lymphocyte; NLPR: neutrophil/(lymphocyte\*platelet); SII (neutrophil\*platelet/lymphocyte): systemic inflammatory index; SIRI (neutrophil\*monocyte/lymphocyte): systemic inflammatory response index; AISI (neutrophil\*platelet\*monocyte/lymphocyte): aggregate index of systemic inflammation. ) were derived from baseline CBC tests. **Name:** C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Complete Blood Count (CBC) values, and indexes derived from the CBC. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** As an inflammatory index. **Measure:** C-Reactive Protein (CRP) **Time Frame:** Baseline **Description:** As an inflammatory index. **Measure:** Erythrocyte Sedimentation Rate (ESR) **Time Frame:** Baseline **Description:** As a hematological inflammatory index **Measure:** Neutrophil/Lymphocyte Rate (NLR) **Time Frame:** Baseline **Description:** As a hematological inflammatory index **Measure:** Monocyte/Lymphocyte Rate (MLR) **Time Frame:** Baseline **Description:** As a hematological inflammatory index **Measure:** Platelet/Lymphocyte Rate (PLR) **Time Frame:** Baseline **Description:** As a hematological inflammatory index **Measure:** Neutrophil/(Lymphocyte*Platelet) Rate (NLPR) **Time Frame:** Baseline **Description:** As a hematological inflammatory index **Measure:** (neutrophil*platelet/lymphocyte): Systemic Inflammatory Index (SII) **Time Frame:** Baseline **Description:** As a hematological inflammatory index **Measure:** (neutrophil*monocyte/lymphocyte): Systemic Inflammatory Response Index (SIRI) **Time Frame:** Baseline **Description:** As a hematological inflammatory index **Measure:** (neutrophil*platelet*monocyte/lymphocyte): Aggregate Index of Systemic Inflammation (AISI) **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical diagnosis of lumbar brucella spondylodiscitis in the past 5 years * Clinical diagnosis of or lumbar type 1 Modic Changes (MCs) in the past 5 years * Having simultaneously lumbar Magnetic Resonance Imaging (MRI), Complete Blood Count (CBC) test, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) results * Being between the ages of 18-65 Exclusion Criteria: * Cases with inadequate data * Being under 18 years of age and over 65 years of age * Having other infectious spondylodiscitis types than brucella * Having other MCs types than type 1 * Having other non-infectious conditions such as rheumatic spondylodiscitis (ankylosing spondylitis or Andersson lesion) * Having previous or recurrent brucella spondylodiscitis, involved other spinal levels than the lumbar spine **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A total of 35 (17 female and 18 male) patients with brucella spondylodiscitis and 37 (26 female and 11 male) type 1 Modic Changes (MCs) were enrolled in the study. Diagnoses of brucella spondylodiscitis and type 1 MCs were supported by microbiological, serological, and radiological diagnotic tools. Patients' hematological parameters were recorded, and hematological inflammatory indexes (NLR: neutrophil/lymphocyte; MLR: monocyte/lymphocyte; PLR: platelet/lymphocyte; NLPR: neutrophil/(lymphocyte\*platelet); SII (neutrophil\*platelet/lymphocyte): systemic inflammatory index; SIRI (neutrophil\*monocyte/lymphocyte): systemic inflammatory response index; AISI (neutrophil\*platelet\*monocyte/lymphocyte): aggregate index of systemic inflammation. ) were derived from baseline CBC tests. ### Contacts Locations Module #### Locations **Location 1:** **City:** Van **Country:** Turkey **Facility:** Volkan Şah **Zip:** 65040 #### Overall Officials **Official 1:** **Affiliation:** Yüzüncü Yıl Üniversitesi Tıp Fakültesi **Name:** Ali İrfan Baran **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001850 - Term: Bone Diseases, Infectious - ID: D000007239 - Term: Infections - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000013122 - Term: Spinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M15961 - Name: Spondylitis - Relevance: HIGH - As Found: Spondylitis - ID: M17996 - Name: Discitis - Relevance: HIGH - As Found: Spondylodiscitis - ID: M23035 - Name: Spondylarthritis - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5129 - Name: Bone Diseases, Infectious - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013166 - Term: Spondylitis - ID: D000015299 - Term: Discitis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432517 **Brief Title:** Sources and Mechanisms of Energy Compensation **Official Title:** Identification of the Sources and Mechanisms of Energy Compensation in Humans #### Organization Study ID Info **ID:** SIAT-IRB-230515-H0653 #### Organization **Class:** OTHER **Full Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-02 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences #### Responsible Party **Investigator Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences **Investigator Full Name:** John R. Speakman **Investigator Title:** Professor, Chief scientist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Excess energy, obesity and obesity-related diseases are important global health issues. Although it is known that obesity is an issue of energy balance, the components of energy expenditure seem to be inter-related in complex non-additive ways. The aim of this study is to explore the downstream impacts of exercise on short term changes in both expenditure and energy intake. The primary question the investigators are asking is whether moderate to high intensity exercise influences the basal energy expenditure and/or energy intake/macronutrient preference in young adult males? (A similar study will be performed on females in a different registration). The investigators will use a specially designed feeding table to measure energy intake and macronutrient intake, which is easy to quantify intake compensation. Basal metabolism will be measured by hood indirect calorimetry. The investigators will explore the factors that influence the level of compensation in expenditure and intake, in particular body composition. Participants will be asked to come to the lab after 10 hours fast for body composition tests including Dual Energy X-ray Absorptiometry(DXA), Magnetic Resonance Image(MRI) and Bioelectrical Impedance Analysis(BIA). They will then be asked (not) to do 30 minutes of moderate-to-vigorous exercise after an energy-limiting breakfast, during which metabolic rate levels and changes in dietary composition will be recorded by gas exchange and standardized buffet. In addition, participants' subjective hunger and preferences will also be recorded by questionnaires. Venous blood will be collected to measure metabolic and hormone factors, blood glucose will be measured by Continuous Blood Glucose Monitor (CGM). **Detailed Description:** 81 participants will be recruited by posters and Wechat. The sample size is calculated using the paired t-test in power analysis, in which α value is 0.05, β value is 0.8, standard deviation is 372 (calculated from the energy intake data in the preliminary trial), and the difference is 108. The alternative hypothesis is greater than 108. The experiment lasted for 14 days, of which two and a half days will be carried out in the laboratory, and the other time only need to wear devices and live freely, which will not affect the normal life. The experiment is mainly divided into three parts: 1. Body composition: Items include weight, height, body fat mass (MRI), bone mass (DAX), body density (BODPOD), lean mass (MRI) and 3D parameters (3D scan). The participants will be required to fasting for at least 10 hours. After the test, they will be equipped with continuous glucose monitoring equipment (CGM), motion monitoring equipment (GT3X) and ambient temperature monitoring equipment (ibutton). 2. Controlled trial: The specific detection contents include resting energy expenditure (REE), active energy expenditure (AEE) and energy intake. The investigators will provide participants with three meals, as an energy restricted breakfast, a standard lunch and supper for dietary component testing. The subjective hunger and eating preference rate of participants will be measured by Visual Analogue Scale (VAS) and questionnaires. Non-physical activities such as working, reading and watching movies will be allowed during the experiment. Venous blood will be collected at several specific points (fasting 10 hours, after breakfast, before lunch and after lunch). In addition, sweat, urine and feces will also be collected. 3. Exercise trial: The schedule is the same as the control trial except for Blood drawing time and 30 minutes of power bike after breakfast, the intensity is 100 watt with 1 minute 25 watt break every 5 minute during the exercise. Venous blood will be collected at several specific points in time (just after exercise, before lunch and after lunch). ### Conditions Module **Conditions:** - Energy Expenditure - Exercise - Energy Intake - Food Preferences **Keywords:** - Energy compensation - Energy balance - Food Preferences ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 81 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** BMI≥18.5, age between 18-40 years old, 81subjects. **Intervention Names:** - Other: Power Bike（Ergoselect 100P） **Label:** Moderate to high intensity exercise **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Moderate to high intensity exercise **Description:** Changes in the participants' energy balance will be measured through moderate to high intensity exercise. Observation of food intake, body composition, metabolic rate, food assimilation rate. **Name:** Power Bike（Ergoselect 100P） **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Macronutrients preference will be recorded by the feeding table, macronutrient preference will be calculated in percentage(%). **Measure:** Macronutrient preference **Time Frame:** During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes. **Description:** Response on standard feeding table, the food consumption will be recorded continuously by balances underneath each food dish. The total energy intake will be calculated in kilojoule (KJ). **Measure:** Energy intake **Time Frame:** During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes. **Description:** Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Metabolic rate (oxygen consumption and carbon dioxide production) are monitored for 40 minutes. The last 10 minutes is used as the measurement. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements. Validation via an alcohol burn will be performed monthly. **Measure:** Basal metabolic rate **Time Frame:** The detection time spans over two days, the control day and the exercise day, from 8:00 am to 5:00 pm, with tests being conducted every hour and each test lasting for half an hour. #### Secondary Outcomes **Description:** Blood glucose will be recorded by the continuous glucose monitoring system(CGM) in mmol/L. **Measure:** Blood glucose **Time Frame:** Wear it for a total of 4 consecutive days, including the physical examination day, the control day, the exercise day, and the day following the exercise day. **Description:** Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days. **Measure:** Physical activity **Time Frame:** Wear it for 14 days from the physical examination day **Description:** The iButton (DS1921G) monitors will be provided for the assessment of both indoor and outdoor temperature of their living environment in centigrade(℃). The iButtons can be affixed to the hand bag (or clothes) to measure the subject exposure temperature, an indoor wall of home and workplace, and the building outside to measure the outdoor temperature using a strip of adhesive, water resistant, medical grade tape. **Measure:** Ambient temperature **Time Frame:** Wear it for 14 days from the physical examination day **Description:** Levels of circulating hormones (including leptin, insulin, ghrelin etc) will be measured when fasted and after a standard intervention meal. Levels of circulating hormones in the serum will be measured by ELISA (Bio Tek, Synergy4) in mmol/L. **Measure:** Circulating Biochemical indexes and hormones **Time Frame:** The venous blood of volunteers will be collected 10 times on control and exercise days. (Control day: fasting, 1,2,3,4 hours after breakfast and 2 hours after lunch. Exercise day: 0,1,2 hours after exercise and 2 hours after lunch) **Description:** Physical activity will be carried out by the Ergoselect 100P(Power bike) at 100 watts **Measure:** Exercise **Time Frame:** 30 minutes after breakfast(only on the exercise day), it last for 39 minutes, 30 minutes at 100 watts and 9 minutes at 25 watts. **Description:** Basal metabolic rate will be recorded by the Quark PFT ergo, The energy expenditure will be calculated in kilojoule (kj). **Measure:** Exercise metabolic rate **Time Frame:** 30 minutes after breakfast(only on the exercise day), it last for 39 minutes, 30 minutes at 100 watts and 9 minutes at 25 watts. **Description:** Volunteers will be asked to fast for 10 hours and measured fasting weight (kilogram, kg) with light clothes and no shoes. **Measure:** Weight **Time Frame:** On the first morning of the experiment, it last for 10 minutes. **Description:** Height will be measured by seca 217 stable stadiometer in meter(m). **Measure:** Height **Time Frame:** On the first morning of the experiment, it last for 10 minutes. **Description:** Waist circumferences will be measured using a whole body laser scanner in centimeter(cm). **Measure:** Waist circumferences **Time Frame:** On the first morning of the experiment, it last for 15 minutes. **Description:** Hip circumferences will be measured using a whole body laser scanner in centimeter(cm). **Measure:** Hip circumferences **Time Frame:** On the first morning of the experiment, it last for 15 minutes. **Description:** Bone mineral density will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi). **Measure:** Bone mineral density **Time Frame:** On the first morning of the experiment, it last for 8 minutes. **Description:** Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). and Bioimpedance Analysis (Tanita, MC-980). **Measure:** Fat mass **Time Frame:** On the first morning of the experiment, it last for 30 minutes. **Description:** Fat free mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). and Bioimpedance Analysis (Tanita, MC-980). **Measure:** Fat free mass **Time Frame:** On the first morning of the experiment, it last for 30 minutes. **Description:** Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer. **Measure:** Blood pressure **Time Frame:** On both the control and exercise days, blood pressure will be measured prior to the basic energy expenditure(≈8:00 am), it last for 5 minutes. **Description:** Body temperature will be measured during lunch using a thermal imager（Fluke RSE600）in centigrade(℃). **Measure:** Body temperature **Time Frame:** On both the control and exercise days, the change of body temperature will be measured during lunchtime and suppertime, each test lasting for 40 minutes. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy adults (men) * 18-40 years old * BMI (body mass index)≥18.5 kg/m2 Exclusion Criteria: * Those who have undergone surgery in the past 6 months. * People are requiring long-term medication. * People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, et al. * People have digestive diseases, like gastric ulcer, pancreatitis, Intestinal obstruction, et al. * People have sports injury, like fracture, Joint injury, et al. * Those who have recently lost weight for various medical reasons (e.g. cancer, etc.). * People are losing weight by tablets. * People are suffering from infectious diseases (e.g. HIV, etc.) * People have blood phobia, pathological hypo or hyper tension. * People with impaired glucose tolerance. * Those who are afflicted with claustrophobia. **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** John R Speakman **Phone:** +8615810868669 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Li Xue **Phone:** 13538042185 **Role:** CONTACT #### Locations **Location 1:** **City:** Shenzhen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** John R Speakman, PhD - **Phone:** +8615810868669 - **Role:** CONTACT **Country:** China **Facility:** Shenzhen Institute of Advanced Technology **State:** Guangdong **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences **Name:** John Speakman **Role:** STUDY_CHAIR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432504 **Brief Title:** Variation in the Impact of Coffee on the Metabolic Rate **Official Title:** Variation in the Impact of Coffee on the Metabolic Rate #### Organization Study ID Info **ID:** SIAT IRB 221115H0629 #### Organization **Class:** OTHER **Full Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-02 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences #### Responsible Party **Investigator Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences **Investigator Full Name:** John R. Speakman **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to explore variation in the impact of coffee on metabolic rate. The investigators plan to recruit healthy participants, half male and half female. **Detailed Description:** The investigators will study the variation in the impact of coffee on metabolic rate and investigate the impacts of age, sex, body composition and regularity of habitual coffee consumption on this effect. The investigators will recruit healthy participants, half male and half female. Participants will be required to perform no strenuous exercise for 14 hours and no moderate of vigorous exercise for 2 hours before the measurements. When the participants arrive at the lab on the day of the experiment, they will sign an informed consent form, a health history questionnaire and a daily coffee consumption questionnaire. Participants will be randomly allocated into 3 groups and given 180mls of coffee to consume containing 100, 200 or 300 mg of caffeine. A fourth group will be dosed with 100 mg of caffeine containing 13C uniform labelled caffeine to trace the pattern of caffeine degradation via the appearance of 13CO2 in the breath and labelled compounds in the urine. The primary outcome is the change in resting metabolic rate from before and after coffee drinking. Secondary outcome measures are heart rate, electrocardiogram, blood pressure, body temperature which will be measured before and after the coffee consumption. Professional nurses will take 8ml of venous blood from all participants as genotyping blood samples. Genomic DNA will be extracted from whole blood samples and analysed for single nucleotide polymorphisms (SNPS). ### Conditions Module **Conditions:** - Healthy **Keywords:** - Coffee - Caffeine - Metabolic rate - Caffeine clearance ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel Assignment ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants will drink 180 mls coffee **Intervention Names:** - Other: Caffeine content **Label:** caffeine content 100mg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The participants will drink 180 mls coffee. **Intervention Names:** - Other: Caffeine content **Label:** caffeine content 200mg **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The participants will drink 180 mls coffee **Intervention Names:** - Other: Caffeine content **Label:** caffeine content 300mg **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** The participants will drink 180 mls coffee (caffeine content 100mg) containing 13C labelled caffeine to trace the pattern of caffeine degradation. **Intervention Names:** - Other: Caffeine content **Label:** 13C3 caffeine content 100mg **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 13C3 caffeine content 100mg - caffeine content 100mg - caffeine content 200mg - caffeine content 300mg **Description:** Participants will drink the same volume of coffee with different amounts of caffeine. **Name:** Caffeine content **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (COSMED). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Resting energy expenditure will be measured before and after coffee consumption. The extra energy expenditure is equal to the resting energy expenditure after drinking coffee minus the resting energy expenditure before drinking coffee. **Measure:** Resting energy expenditure **Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours. **Description:** The contents of metabolites will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ). **Measure:** Urine metabolites **Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours. **Description:** Gases will be collected before and after coffee consumption, Gases will be measured by CO2 isotope analyzer (CCIA2-912) to observe the change of labelled CO2. **Measure:** Expired gases **Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours. #### Secondary Outcomes **Description:** Body temperature of participants will be measured by body temperature patch (RIT-P02-MED) before and after coffee consumption. **Measure:** Body temperature **Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours. **Description:** ECG of participants will be measured by Amu ECG belt before and after coffee consumption, the changes in P wave, PR interval, PR segment, QRS wave group, J point, ST segment, T wave, QT interval, and U wave will be observe. **Measure:** Electrocardiogram (ECG) **Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours. **Description:** Venous blood collected by nurses, blood samples will be used for whole genome exon sequencing to analyze single nucleotide polymorphisms. **Measure:** Blood samples **Time Frame:** Baseline : empty stomach On the first moring of experiment. **Description:** Systolic and diastolic blood pressure of participants will be measured by Omron digital sphygmomanometer before and after coffee consumption. **Measure:** Blood pressure **Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours. **Description:** Height will be measured by seca 217 stable stadiometer. **Measure:** Height **Time Frame:** On the first moring of experiment, it lasts 5 minutes. **Description:** Fasting body weight will be measured by Bioimpedance Analysis (TANITA, MC-980). **Measure:** Body weight **Time Frame:** On the first moring of experiment, it lasts 5 minutes. **Description:** Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). **Measure:** Fat mass **Time Frame:** On the second moring of experiment, it lasts 10 minutes. **Description:** Fat free mass will be Bioimpedance Analysis (TANITA, MC-980). **Measure:** Fat free mass **Time Frame:** On the first moring of experiment, it lasts 5 minutes. **Description:** Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi). **Measure:** Bone mass **Time Frame:** On the first moring of experiment, it lasts 10 minutes. **Description:** Heart rate will be measured by Omron sphygmomanometer. **Measure:** Heart rate **Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours. **Description:** Body water, extracellular fluid and intracelluar fluid will be measured by Bioimpedance Analysis (TANITA, MC-980). **Measure:** Body water, extracellular fluid and intracelluar fluid **Time Frame:** On the first moring of experiment, it lasts 0.5 hours and 3 hours. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Healthy adults 18-40 years old Exclusion Criteria: Those who have undergone surgery in the past 6 months. People are requiring long-term medication. People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, etc. People have digestive diseases, like gastric ulcer, pancreatitis, intestinal obstruction, etc. Those who have recently lost weight for various medical reasons ( like cancer, etc.). People are suffering from infectious diseases ( like HIV, etc.). People have blood phobia, pathological hypo or hyper tension. People with impaired glucose tolerance. Those who are afflicted with claustrophobia. **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** John R Speakman, PhD **Phone:** 13466654659 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Huanan Zhang, Bachelor **Phone:** 13371016641 **Role:** CONTACT #### Locations **Location 1:** **City:** Shenzhen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hannan Zhang, Bachelor - **Phone:** 13371016641 - **Role:** CONTACT **Country:** China **Facility:** Shenzhen Institute of Advanced Technology **State:** Guangdong **Status:** RECRUITING **Zip:** 518055 #### Overall Officials **Official 1:** **Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences **Name:** John R Speakman, PhD **Role:** STUDY_CHAIR ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000697 - Term: Central Nervous System Stimulants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000058915 - Term: Purinergic P1 Receptor Antagonists - ID: D000058914 - Term: Purinergic Antagonists - ID: D000058905 - Term: Purinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5373 - Name: Caffeine - Relevance: HIGH - As Found: 800 - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M13629 - Name: Phosphodiesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T370 - Name: Caffeine - Relevance: HIGH - As Found: 800 ### Intervention Browse Module - Meshes - ID: D000002110 - Term: Caffeine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432491 **Brief Title:** The Association Between Core Temperature and Health **Official Title:** Study to Explore How Core Temperature Reduction Influence Health #### Organization Study ID Info **ID:** KYLLHS-20240201A #### Organization **Class:** OTHER **Full Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences ### Status Module #### Completion Date **Date:** 2026-05-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-01 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shenzhen University General Hospital **Class:** OTHER **Name:** The Hong Kong Polytechnic University #### Lead Sponsor **Class:** OTHER **Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences #### Responsible Party **Investigator Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences **Investigator Full Name:** John R. Speakman **Investigator Title:** Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if cold water drinking could promote body composition and further extend healthy lifespan in Chinese older adults. The main questions it aims to answer are: 1. Does cold water drinking lower the body fat percentage? 2. Will cold water drinking positively extend lifespan in a long-term Researchers will compare cold water intervention group to a control group (drinking 37℃ water instead) to see if cold water drinking works to promote health and slow down ageing process. Participants will: 1. Drink 4℃ or 37℃ water 4 times (9a.m., 12p.m., 15p.m., 18p.m.) every day for 6 months. 2. Visit the institute and health checkup department for tests and checkup at baseline, the end of the 3rd month, and the end of 6th month. **Detailed Description:** According to pilot study, we found 4℃ water could significantly reduce core body temperature. Thus, we aim to explore whether 4℃ water drinking could promote body composition and further help to extend lifespan. Participants will be randomly divided into intervention (drinking 4℃ water at 9a.m., 12p.m., 15p.m., 18p.m.) and control group (drinking 37℃ water at 9a.m., 12p.m., 15p.m., 18p.m.) for 6-month intervention. Tests will be conducted in Shenzhen Institute of Advanced Technology, while checkup will be tested at Health Checkup Department of Shenzhen University General Hospital. Body composition will be tested by Magnetic Resonance Imaging (MRI), Dual-Energy X-Ray Absorptiometry (DEXA), and TANITA (bioelectrical method). In addition, we will test participants' waist and hip circumferences using 3D scanning. Besides, we will test core body temperature and brown adipose tissue. Apart from above main outcomes, we will also test their physical activity, food intake, metabolic rate, glucose, IL-6, TNF-alpha, HDL, LDL, insulin level. Meanwhile, ageing biomarkers, namely Phenotypic Age, eye fundus image, facial changes, bone density, gut microbiota, GlycanAge, will also be measured. The whole intervention period will last for 6 months. All the tests and checkup will be tested at baseline, the end of the third month and the endpoint of the study. ### Conditions Module **Conditions:** - Body Temperature Changes - Body Composition - Aging **Keywords:** - Body temperature - Body composition - Aging ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be randomly divided into intervention group and control group. Intervention group will drink 4℃ water while control group will drink 37℃ water for 6 months. ##### Masking Info **Masking:** DOUBLE **Masking Description:** All the participants will only get access to their own group and will not get access to other group members. The investigator who take charge of MRI test for participants' body composition will not have any idea about grouping. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Volunteers will drink 500ml 4℃ water within 10 minutes at 9a.m., 12p.m., 15p.m., 18p.m. everyday for 6 months. **Intervention Names:** - Behavioral: Drinking cold water **Label:** 4℃ water drinking group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Volunteers will drink 500ml 37℃ water within 10 minutes at 9a.m., 12p.m., 15p.m., 18p.m. everyday for 6 months. **Label:** 37℃ water drinking group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - 4℃ water drinking group **Description:** Volunteers in the intervention group will be asked to drink up 500 ml 4℃ water within 10 minutes four times per day throughout the study. **Name:** Drinking cold water **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of albumin in g/L assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of creatinine in umol/L assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of C-reactive protein in mg/dL assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Percentage of lymphocyte assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Volume of mean (red) cell assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Coefficient of variation of red blood cell size (red cell distribution width) assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of alkaline phosphatase in U/L assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Number of white blood cell (white blood cell count) in 1000 cells/uL assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. Index of albumin, creatinine, glucose, c-creative protein, lymphocyte percentage, mean corpuscular volume, red cell distribution width, alkaline phosphatase, white blood cell count will be examined and calculated into Phenotypic Age. **Measure:** Calculation of Phenotypic Age based on blood test **Time Frame:** The calculation will cost 5 minutes. The calculation will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Bone mass will be measured by DEXA (Horizon Wi). Volunteers will be asked to lie on a special DEXA x-ray table. The technologist will help position your correctly and use positioning devices such as foam blocks to help hold the desired position. As the arm of the DEXA machine passes over the body, IT uses two different x-ray beams. The beams use very little radiation to keep the test safer, and help to distinguish bone from other tissues. The scanner translates the bone density measurement data into pictures and graphs. Bone is most easily seen in white, while the, fat and muscle tissue look like shadows in the background on the technologist's computer monitor. **Measure:** Bone density in g/cm^2 assessed by Horizon Wi **Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Volunteers will go to the Health Management Center of Shenzhen University General Hospital, where professional doctors will use a photocoherence tomography scanner (Spectralis OCT) for fundus examination, and fundus imaging will be collected without invasiveness and harm. Volunteers need to sit comfortably in a chair and move their face close to the camera device. Technologist will show where to place forehead and chin. Nothing touches volunteers' eye during retinal imaging. **Measure:** Eye fundus imaging assessed by Spectralis OCT **Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Facial features are captured using an infrared thermal imager (Fluke RSE600), which are then analyzed using artificial intelligence. When shooting, wait for the thermal imager to focus and press the shutter. During image acquisition, the frame should contain only one subject, whose face and head information are fully collected, and the area above the neck accounts for more than 35% of the thermal image captured. During the collection process, volunteers are reminded to look up at the camera, not to make expressions, not to wear glasses that cover their faces, masks, etc. In the event that the volunteer has bangs or long hair covering their face, the volunteer should be reminded to put on a headband and tie their hair back. **Measure:** Picture of facial features assessed by Fluke RSE600 **Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Muscle strength will be measure by Jamar Plus+ Digital Hand Dynamometer. Volunteers will comfortably arrange the instrument in his/her hand. Have volunteers squeeze with their maximum strength. The peak-hold needle will automatically record the highest force exerted. **Measure:** Muscle strength in kilogram assessed by Jamar Plus+ Digital Hand Dynamometer **Time Frame:** Ten minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina. Volunteers will collect their feces by themselves using a specialized feces collection tubes. They need to submit the samples to the researcher within 30 minutes after collection or they need to first store in the freezer and then submit the sample when available. **Measure:** Microbiome assessed by Illumina **Time Frame:** Feces will be collected by volunteers themselves and send to the researchers. Feces will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** The researcher will take a drop of blood from the volunteers' finger stick, use the kit to store the fingerstick blood, and then send it to the company for testing. Biological age score based on glycan biomarkers that indicate inflammation will be available in 3-5 weeks. **Measure:** Score of GlycanAge assessed by GlycanAge kit **Time Frame:** Ten minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. #### Primary Outcomes **Description:** Volunteers will swallow an electronic capsule called e-Celsius (BodyCap, France) which will be activated before use. Four hours after swallowing, the e-Celsius will enter intestine and data collection will start. A device call e-Viewer (KIT EPERF CE-SW, France) will be used to connect the capsules and collect data. **Measure:** Value of core body temperature in centigrade assessed by e-Celsius **Time Frame:** Twenty-four hours every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Volunteers will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes. **Measure:** Value of weight in kilogram assessed by Seca body weight scale **Time Frame:** Five minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Measured by Seca 217 Stable Stadiometer. Volunteers should not wear shoes and socks. Stand on the stadiometer platform with back against the wall and feet together. Stand up as straight as possible with heels, back, shoulders, and head all touching the wall. Tuck in chin and look straight ahead. **Measure:** Value of height in meters assessed by Seca 217 stadiometer **Time Frame:** Five minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** BMI will be calculated based on weight and height according to the formula: BMI=Weight/Height\^2 **Measure:** Value of body mass index (BMI) calculated by weight and height **Time Frame:** The calculation will cost two minutes every three months for the 6 months of the experiments.The calculation will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ). Volunteers should wear no metal jewelries or with metal implants. They should lie down on a movable table and be fasten by technologists. Volunteers should hold still during the test and perform a few small tasks, such as exhale, inhale, and hold breath following the broadcast. **Measure:** Body composition- volume of fat mass in cm^3 assessed by uMR 790 **Time Frame:** Fifteen minutes every three months for the 6 months of the experiments.The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980). Demographic information of volunteers should be entered before test, including ID number, sex, age, height. When the signal showing the machine is ready, volunteers should stand on the scale without shoes, socks or any pieces which might influence weight. According to the instruction of display screen, volunteers need to hold the handle tightly. **Measure:** Body composition-weight of fat free mass in gram assessed by Tanita MC-980 **Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Fat free mass will be measured by DEXA (Horizon Wi). Volunteers will be asked to lie on a special DEXA x-ray table. The technologist will help position your correctly and use positioning devices such as foam blocks to help hold the desired position. As the arm of the DEXA machine passes over the body, IT uses two different x-ray beams. The beams use very little radiation to keep the test safer, and help to distinguish bone from other tissues. The scanner translates the bone density measurement data into pictures and graphs. Bone is most easily seen in white, while the, fat and muscle tissue look like shadows in the background on the technologist's computer monitor. **Measure:** Body composition-wegiht of fat mass in gram assessed by Horizon Wi **Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Waist circumferences will be measured using a whole body laser scanner (TG2000-F). Volunteers should wear tight underwear during test and stand in front of the machine according to the stickers of instruction. Do some small movement according to instruction. **Measure:** Waist circumferences in centimeter assessed by TG2000-F **Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Hip circumferences will be measured using a whole body laser scanner (TG2000-F). Volunteers should wear tight underwear during test and stand in front of the machine according to the stickers of instruction. Do some small movement according to instruction. **Measure:** Hip circumferences in centimeter assessed by by TG2000-F **Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** The infrared thermal imager (Fluke RSE600) will be used to measure brown adipose tissue around clavicle. Each subject was in a relaxed "steady-state" within a familiar environment. They were seated in an upright posture, with arms adducted and with head, neck, and shoulders unclothed, in the center of the study room, away from all heat-emitting objects and 1.0 m away from a thermal imaging camera fixed on a tripod at a set distance, 1 m, from the floor. This positioning ensured comfort as well as the optimum position for visualization of the supraclavicular BAT depots. 5 images were taken at 1-minute intervals before each thermal challenge and represented the control period. Each subject then placed 1hand into cool tap water (20℃).The increase in temperature in the thermal area in the supraclavicular region was further collected. **Measure:** Brown adipose tissue-areas of temperature increase in cm^2 assessed by Fluke RSE600 **Time Frame:** Fifteen minutes every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. #### Secondary Outcomes **Description:** Physical activity of the volunteers will be recorded using accelerometer (GT3X) worn near the hip for a consecutive period of 7 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days. The acceleration of three axises will be collected and then calculated into the intensity of physical activity. **Measure:** Intensity of physical activity in three types (light, moderate, vigorous) assessed by GT3X **Time Frame:** Seven days every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Food intake was monitored using the 24-hour Dietary Review questionnaire (a retrospective record of food intake (quantity and frequency) over the past 24 hours using a self-reported questionnaire). **Measure:** Weight of food intake in gram assessed by 24-hour Dietary Review Questionnaire **Time Frame:** One day every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The volunteer attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Metabolic rate (oxygen consumption and CO2 production) are monitored for 40 minutes. The last 10 minutes is used as the measurement. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements. Validation via an alcohol burn will be performed monthly. **Measure:** Resting metabolic rate in kcal assessed by Cosmed **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for glucose test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of glucose in mmol/L assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for IL-6 test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of IL-6 in ng/L assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for TNF-Alpha test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of TNF-Alpha in ng/mL assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for HDL test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of High-Density Lipoprotein (HDL) in mmol/L assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for LDL test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of Low-Density Lipoprotein (LDL) in mmol/L assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for TG test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of triglyceride (TG) in mmol/L assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. **Description:** Venous blood sample will be collected by professional nurse for insulin test in the morning after 12 hour fasting and be examined by Shenzhen University General Hospital. **Measure:** Concentration of insulin in mU/L assessed by clinical blood test **Time Frame:** Fifteen minutes of blood test every three months for the 6 months of the experiments. The data will be collected at baseline, the end of the 3rd month, and the end of the 6th month. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged between 50 and 65 years old (including 50 and 65) * No surgery in the past 6 months * Healthy (No metabolic diseases, cardiovascular diseases, lung diseases (COPD, asthma, et al.), endocrine diseases and gastrointestinal diseases) * Based in Shenzhen during the whole study period * No significant change on body weight in the past 3 months Exclusion Criteria: * Those who need to take medication for a long term (including diet pills) * On a diet * Disabled * Females who are trying to get pregnant, pregnant, or breastfeeding * Presence of a metal implant in the body (e.g. pacemaker) * Those with claustrophobia * Those with blood phobia, pathological hypotension or hypertension * Those who are in other intervention studies **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** John R Speakman, PhD **Phone:** 15810868669 **Phone Ext:** 0755-86528487 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yinuo Wang, Master **Phone:** 15734075325 **Phone Ext:** 0755-86528487 **Role:** CONTACT #### Locations **Location 1:** **City:** Shenzhen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** John R Speakman, PhD - **Phone:** 15810868669 - **Phone Ext:** 0755-86528487 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Yinuo Wang, Master - **Phone:** 15734075325 - **Phone Ext:** 0755-86528487 - **Role:** CONTACT **Country:** China **Facility:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences **State:** Guangdong **Zip:** 518055 #### Overall Officials **Official 1:** **Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences **Name:** John R Speakman, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5111 - Name: Body Temperature Changes - Relevance: HIGH - As Found: Body Temperature Changes ### Condition Browse Module - Meshes - ID: D000001832 - Term: Body Temperature Changes ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432478 **Brief Title:** 3D Printed Custom Applicators for HDR BT (DISCO) **Official Title:** Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO) #### Organization Study ID Info **ID:** DISCO #### Organization **Class:** OTHER **Full Name:** Royal North Shore Hospital ### Status Module #### Completion Date **Date:** 2028-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-09 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-01-11 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Royal North Shore Hospital #### Responsible Party **Investigator Affiliation:** Royal North Shore Hospital **Investigator Full Name:** Marita Morgia **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators. **Detailed Description:** Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. Current workflows for designing and constructing custom applicators with wax moulds are complex, time consuming and can result in a device that fails to meet original design specifications dictated by the planning system. In contrast, 3D-printed custom applicators provide the ability to design and print patient-specific devices that match optimal design specifications. The workflow for 3D-printed applicators is also more efficient with lower turn-around time and labour/equipment costs, and ensures a more robust product for treatment. Despite these advantages there is currently no radiotherapy department offering 3D printed custom applicators at present. This study will investigate the feasibility of successfully treating gynaecological cancers with 3D-printed custom applicators. ### Conditions Module **Conditions:** - Gynecologic Cancer - Endometrial Cancer - Vaginal Cancer - Vulva Cancer **Keywords:** - 3D-printed applicator - Gynaecological Cancer - Brachytherapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients **Intervention Names:** - Device: 3D-printed custom applicator **Label:** Gynaecological HDR brachytherapy patients **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Gynaecological HDR brachytherapy patients **Description:** 3D-printed custom applicator **Name:** 3D-printed custom applicator **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** To demonstrate the feasibility of successfully simulating, planning and treating a HDR BT gynaecological patient with a 3D-printed internal mould, such that there is a dosimetric and/or clinical benefit for the patient relative to the current standard of care (cylindrical vaginal applicator). Successful treatment indicated by achieving no adverse events or difference to standard of care, and dosimentic comparisons of the 3D printed applicator plan to the cylinder plan are equivalent or better. Feasibility also determined by achieving no logistical or design issues in using the 3D printed applicators clinically. **Measure:** Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators. **Time Frame:** 5 years #### Secondary Outcomes **Description:** RT acute and late side effects will be assessed and quantified using CTCAE criteria via clinician assessment and PROs **Measure:** To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria **Time Frame:** 5 years **Description:** The plan quality of treatment plans generated for 3D-printed moulds and cylindrical applicators will be compared using dosimetric indices including target coverage (D90, Dose Homogeneity index) and organs at risk doses (D2cc, D1cc and point max) as well as patient comfort. statistical analysis (p-value) and comparison with international guidelines will be used to assess the quality of the treatment plans. **Measure:** To compare quality of treatment plans generated for 3D-printed moulds and cylindrical applicators assessed by dosimetric indices, statistical analysis (p-value) and comparison with international guidelines. **Time Frame:** 5 years **Description:** Feasibility of a pre-planned MR-only procedure will be determined using any of the patients that are accrued to the study who have both a CT and MRI performed at the time of simulation. The applicator and treatment plan will be generated based on the MRI and both compared to the CT-based plan and applicator. Feasibility will be indicated by generating equivalent plan quality and applicators from both methods. **Measure:** Determine feasibility of a pre-planned MR-only procedure **Time Frame:** 5 years **Description:** The initial and final CT plan dosimetry will be compared to determine the feasibility of an initial CT-only process. Clinically insignificant differences between the plan dosimetry metrics and all within clinical tolerances will be used to quantify the difference. statistical analysis (p-value) will be used to assess the quality of the treatment plans. **Measure:** To determine the feasibility of an initial CT-only process by comparing initial and final CT plan dosimetry assessed by dosimetric indices, clinical tolerances, and statistical analysis (p-value). **Time Frame:** 5 years **Description:** The feasibility of an optimised 3D-printed applicator design based on the cylinder fitting procedure will be assessed by comparison of the 3D-printed clinical applicators with applicators derived from CT/MR of the vault in a relaxed state with an expansion applied based on the size of the cylinder applied in the fitting procedure. Feasibility will be determined by looking for a correlation between the size of the 3D printed clinical applicators and the size of the cylinders tolerated by the patient in the fitting procedure. **Measure:** Determine feasibility of optimising 3D-printed applicator design based on the cylinder fitting procedure **Time Frame:** 5 years **Description:** Procedure times will be recorded as per ARIA carepath tasks and time taken within the 3D-printed custom applicator workflow compared to the standard of care cylinder applicator workflow with equivalent or less time taken deemed acceptable **Measure:** To measure resources such as procedure times and demonstrate acceptable timescales for the process **Time Frame:** 5 years **Description:** Costs associated with the 3D-printed design process will be defined and compared with the standard of care process via economic analysis of the resourcing and unit-price estimates in each arm of the respective workflows **Measure:** To define the resource costs associated with the 3D-printed design process and perform a cost comparison with the standard of care process **Time Frame:** 5 years **Description:** Patient experience and acceptability of the 3D-printed simulation and treatment processes will be assessed with the EORTC QLQ-C30 questionnaires and success measured by comparison with the standard of care vaginal cylinder process. Questionnaires include questions with a scale of 1-4 where a higher number indicates a worse experience and a scale of 1-7 where a lower number indicates a worse experience. **Measure:** To assess patient experience and acceptability of the process with questionnaires **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to give informed consent * Patients indicated for intracavitary brachytherapy * FIGO stage I-IVA * ECOG 0-2 * Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer Exclusion Criteria: * Pregnancy * Patients contraindicated for brachytherapy * Inflammatory bowel disease/history of adhesions/bowel obstruction * Renal transplant/horseshoe kidney * Patients with significant LVSI or pelvic sidewall invasion * Patients requiring interstitial brachytherapy implants **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marita Morgia, MD **Phone:** 9463 1300 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jeremy Booth, PhD QMP **Phone:** 94631300 **Role:** CONTACT #### Locations **Location 1:** **City:** St Leonards **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Carol Kwong - **Phone:** 02 9463 1339 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Heidi Tsang - **Phone:** 02 9463 1340 - **Role:** CONTACT **Country:** Australia **Facility:** Royal North Shore Hospital **State:** New South Wales **Status:** RECRUITING **Zip:** 2067 #### Overall Officials **Official 1:** **Affiliation:** Royal North Shore Hospital **Name:** Marita Morgia, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Royal North Shore Hospital **Name:** Jeremy Booth, PhD QMP **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000014623 - Term: Vaginal Diseases - ID: D000014845 - Term: Vulvar Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17373 - Name: Vaginal Neoplasms - Relevance: HIGH - As Found: Vaginal Cancer - ID: M17589 - Name: Vulvar Neoplasms - Relevance: HIGH - As Found: Vulva Cancer - ID: M19235 - Name: Endometrial Neoplasms - Relevance: HIGH - As Found: Endometrial Cancer - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M17371 - Name: Vaginal Diseases - Relevance: LOW - As Found: Unknown - ID: M17588 - Name: Vulvar Diseases - Relevance: LOW - As Found: Unknown - ID: T5829 - Name: Vaginal Cancer - Relevance: HIGH - As Found: Vaginal Cancer - ID: T5877 - Name: Vulvar Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016889 - Term: Endometrial Neoplasms - ID: D000014625 - Term: Vaginal Neoplasms - ID: D000014846 - Term: Vulvar Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432465 **Brief Title:** tDCS to Decrease Opioid Relapse (UH3) **Official Title:** tDCS to Decrease Opioid Relapse (UH3) #### Organization Study ID Info **ID:** 1317333 #### Organization **Class:** OTHER **Full Name:** Butler Hospital #### Secondary ID Infos **ID:** 4UH3DA047793 **Link:** https://reporter.nih.gov/quickSearch/4UH3DA047793 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-17 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Drug Abuse (NIDA) #### Lead Sponsor **Class:** OTHER **Name:** Butler Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. In Phase I, the EEG provided validation of expected changes in these networks following tDCS stimulation of the DLPFC. In this current phase (II), the investigators will perform a larger randomized clinical trial (RCT) (active vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes. **Detailed Description:** Investigators will perform an RCT in 100 opioid dependent participants who recently initiated buprenorphine or methadone. Participants will be randomized to receive five sessions of tDCS+CCN priming stimulation vs. sham tDCS+CCN priming. Participants will be assessed three times using electroencephalographic (EEG), once prior to tDCS+CCN priming, right after the completion of 5 sessions of tDCS+CCN priming (one week later), and again 10 weeks later. This phase will address long-term (3- and 6-month) neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes during a paradigm that challenges networks associated with craving (CR) and cognitive control (CCN). During the 24 weeks of buprenorphine or methadone maintenance treatment, the investigators will examine our primary clinical outcome, relapse (opioid use on \>4 days per month and having an opioid positive urine screen), as well as days of opioid use. ### Conditions Module **Conditions:** - Opioid Use Disorder **Keywords:** - opioid craving - buprenorphine - methadone - EEG - transcranial direct current stimulation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network. **Intervention Names:** - Device: tDCS **Label:** tDCS **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network. **Intervention Names:** - Device: tDCS **Label:** sham tDCS **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - sham tDCS - tDCS **Description:** The anode will be placed over the right DLPFC (F4 on the EEG 10-20 system) and the cathode over the left DLPFC65 (F3) using 25cm2 sponges at an intensity of 2mA. Stimulation will be delivered via two saline-soaked surface sponge electrodes and a battery-driven, constant current stimulator (NeuroConn DC Stimulator Plus). This device includes a study mode, in which subject-specific codes are entered to deliver active or sham stimulation, keeping the administrator blinded. Sham stimulation will use a method in which stimulation will be ramped up and back down over a 30-second period at the beginning and end of sham tDCS. **Name:** tDCS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Penn Alcohol Craving (Modified for Opioids) (scoring: 0 - 30, higher scores = more craving) Penn Alcohol Craving (Modified for Opioids) (scoring: 0 - 30, higher scores = more craving) Penn Alcohol Craving (Modified for Opioids) (scoring: 0-30, higher scores = more craving) **Measure:** Changes in opioid craving **Time Frame:** 2 weeks **Description:** frontal theta activity during working memory **Measure:** change in EEG oscillatory targets **Time Frame:** 2 weeks **Description:** Timeline followback interview and urine toxicology **Measure:** lower rates of opioid relapse **Time Frame:** 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: (a) current opioid dependence, (b) between 21-60 years of age, (c) recent initiation of buprenorphine or methadone (≤30days), and (d) enrolled in Butler Hospital's Alcohol and Drug Inpatient Unit, Alcohol and Drug Partial Hospital Treatment Program, Intensive Outpatient Services, or Outpatient Services at Butler Hospital OR receive opioid-treatment services in the community. Exclusion Criteria: (a) current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus), (b) bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder, (c) current suicidality, (d) evidence of significant neurocognitive dysfunction, (e) conditions associated with heightened tDCS risks, e.g., seizure disorder, nonremovable intracranial metal objects (other than dental fillings and dental implants), skin disease or active lesions on the scalp, migraine/other headache disorder with significant active symptoms, traumatic brain injury or skull fracture within the past year, any implanted medical devices or device components that can interact with electromagnetic fields or are controlled by physiological signals, (f) probation/parole requirements or an upcoming move that might interfere with protocol participation, (g) planning to terminate buprenorphine or methadone in less than 3 months, (h) current pregnancy or plan to become pregnant in the next month. **Maximum Age:** 60 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ana M Abrantes, Ph.D. **Phone:** 4014556440 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Julie A Desaulniers, M.S. **Phone:** 4014556219 **Role:** CONTACT #### Locations **Location 1:** **City:** Providence **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ana M Abrantes, Ph.D. - **Phone:** 401-455-6440 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ana M. Abrantes, Ph.D. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Michael Stein, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Butler Hospital **State:** Rhode Island **Status:** RECRUITING **Zip:** 02906 #### Overall Officials **Official 1:** **Affiliation:** Butler Hospital **Name:** Abrantes Abrantes, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Boston University **Name:** Michael Stein, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000079524 - Term: Narcotic-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12244 - Name: Opioid-Related Disorders - Relevance: HIGH - As Found: Opioid Use Disorder - ID: M2057 - Name: Narcotic-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009293 - Term: Opioid-Related Disorders ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: NarcAntag - Name: Narcotic Antagonists - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnTuAg - Name: Antitussive Agents - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M5317 - Name: Buprenorphine - Relevance: LOW - As Found: Unknown - ID: M11671 - Name: Methadone - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432452 **Acronym:** EDIT-CAS **Brief Title:** Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm **Official Title:** Efficacy of Endothelin Receptor Antagonism in Treatment of Coronary Artery Spasm: a Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** 114746 #### Organization **Class:** OTHER **Full Name:** Radboud University Medical Center ### Status Module #### Completion Date **Date:** 2026-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** UMC Utrecht **Class:** OTHER **Name:** Catharina Ziekenhuis Eindhoven **Class:** OTHER **Name:** Maasstad Hospital #### Lead Sponsor **Class:** OTHER **Name:** Radboud University Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** The goal of this randomized clinical trial is to assess if adjunctive bosentan therapy, in comparison to placebo, can reduce the rate of epicardial vasospasm at follow-up spasm provocation CFT (fuCFT) in patients with previously proven epicardial vasospasm on acetylcholine reactivity testing (at index CFT) and ongoing angina(-like) complaints. Participants will * Use either endothelin receptor antagonist or placebo for 10 weeks * Undergo follow-up acetylcholine spasm provocation test after 10 weeks * Answer online questionnaires on angina and quality of life ### Conditions Module **Conditions:** - Coronary Spasm **Keywords:** - epicardial spasm - endothelin receptor antagonism - angina ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Bosentan 62.5 mg twice daily Uptitrated to 125mg twice daily if tolerated after 4 weeks Total 10 weeks **Intervention Names:** - Drug: Endothelin Receptor Antagonist **Label:** Bosentan **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Placebo 62.5 mg twice daily Uptitrated to 125mg twice daily if tolerated after 4 weeks Total 10 weeks **Intervention Names:** - Other: Placebo control **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Bosentan **Description:** Oral capsules twice daily **Name:** Endothelin Receptor Antagonist **Other Names:** - Bosentan **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Oral capsules twice daily **Name:** Placebo control **Other Names:** - Placebo **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Measured with EuroQol 5 Dimensions (EQ5D) and separate SAQ domains. Scores can range from 0-100, with higher scores indicating better health status. **Measure:** Improvement of quality of life **Time Frame:** 10 weeks **Description:** The rate of occurence of microvascular spasm according to COVADIS criteria at fuCFT **Measure:** Microvascular spasm **Time Frame:** 10 weeks **Description:** Circulating endothelin-1 plasma levels in peripheral blood drawn at visit 1. **Measure:** Endothelin levels at baseline **Time Frame:** 10 weeks **Description:** Any deterioration or improvement according to prespecified outcomes measured by repeated spasm provocation test. If a higher dose of acetylcholine is needed to induce epicardial spasm for example, this change will be documented. If microvascular spasm can, but epicardial can not be provoked, this will be documented. The incidence of these changes will be analyzed. **Measure:** Change in spasm provocation reactivity **Time Frame:** 10 weeks **Description:** Assessed by means of repeat laboratory analysis **Measure:** Incidence of liver panel disturbances **Time Frame:** 10 weeks **Description:** Assessed by means of repeat blood pressure measurements **Measure:** Incidence of hypotension **Time Frame:** 10 weeks **Description:** Assessed by (S)AE reporting, during all follow-up contacts **Measure:** Incidence of MACE **Time Frame:** 10 weeks **Description:** Assessed and captured at every follow-up contact moment. **Measure:** Rate of study drug discontinuation / study withdrawal. **Time Frame:** 10 weeks #### Primary Outcomes **Description:** On repeat invasive spasm provocation according to Coronary Vasomotor Disorders International Study Group (COVADIS) criteria. Successful treatment is defined as absence of epicardial vasospasm according to COVADIS criteria during repeat spasm provocation test at 10 weeks. **Measure:** Successful treatment **Time Frame:** 10 weeks #### Secondary Outcomes **Description:** As measured with Seattle Angina Questionnaire (SAQ) summary score and change from baseline to follow-up. Score can range from 0-100, with higher scores indicating better health status. **Measure:** Improvement of anginal complaints **Time Frame:** 10 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Definitive diagnosis of epicardial vasospasm on maximal acetylcholine dose of 100µg (at iCFT) 2. At least 18 years of age 3. On optimal regular care ( current or previous treatment with at least 2 daily anti-anginal medicines i.e. nitrate and calcium channel blocker 4. Continuing episodes of angina(-like) complaints at least once weekly despite 3. 5. Signed online informed consent for participation in NL-CFT registry (the Netherlands Registry of invasive coronary vasomotor function testing), or willing to co-sign for registry at time of inclusion in EDIT-CAS 6. Written informed consent for EDIT-CAS Exclusion Criteria: 1. Systolic blood pressure (SBP) \<85 mmHg measured at Visit 1 2. Significant hepatic impairment at time of iCFT lab (ASAT/ALAT \>3x upper limit of normal (ULN)) or history of liver cirrhosis (Child-Pugh 7-15) 3. Severe anemia (Hb\<6.0mmol/L) without identified cause at time of inclusion 4. Patients with limited life expectancy (\<1 year) 5. Participation in another randomized clinical study with an use of an Investigational Medicinal Product (IMP) up to one month prior to enrolment. 6. Pregnancy, active desire to become pregnant or unwilling to take adequate\* contraceptive measures when of child bearing potential for the duration of 6 months (active medication period + 3 months safety). 7. Known heart failure with reduced ejection fraction\<35% 8. Known pulmonary hypertension of any type 9. Potentially dangerous interaction due to the use of another CYP3A4 or CYP2C9 substrate (e.g. ciclosporin A, glibenclamide, fluconazole, rifampicin, tacrolimus/sirolimus, lopinavir/ritonavir) 10. Repeat spasm provocation test deemed unsafe (e.g. allergic reaction at iCFT) * Adequate in this case meaning if on hormonal contraceptives, additional measures to be taken (e.g. condom). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Peter Damman **Phone:** 0243616785 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Caïa Crooijmans **Phone:** 0243096546 **Role:** CONTACT #### Locations **Location 1:** **City:** Eindhoven **Contacts:** ***Contact 1:*** - **Name:** Annemiek de Vos, MD - **Role:** CONTACT **Country:** Netherlands **Facility:** Catharina Ziekenhuis **State:** Noord-Brabant **Zip:** 5623EJ **Location 2:** **City:** Rotterdam **Contacts:** ***Contact 1:*** - **Name:** Valeria Paradies, MD, PhD - **Role:** CONTACT **Country:** Netherlands **Facility:** Maasstad Hospital **State:** Zuid-Holland **Zip:** 3079DZ **Location 3:** **City:** Nijmegen **Contacts:** ***Contact 1:*** - **Name:** Peter Damman, MD, PhD - **Role:** CONTACT **Country:** Netherlands **Facility:** RadboudUMC **Zip:** 6525GA **Location 4:** **City:** Utrecht **Contacts:** ***Contact 1:*** - **Name:** Tim van de Hoef, MD, PhD - **Role:** CONTACT **Country:** Netherlands **Facility:** UMC Utrecht **Zip:** 3584CX #### Overall Officials **Official 1:** **Affiliation:** Radboud University Medical Center **Name:** Peter Damman, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4117 - Name: Angina Pectoris - Relevance: LOW - As Found: Unknown - ID: M12077 - Name: Muscle Cramp - Relevance: HIGH - As Found: Spasm - ID: M15837 - Name: Spasm - Relevance: HIGH - As Found: Spasm - ID: M6551 - Name: Coronary Vasospasm - Relevance: HIGH - As Found: Coronary Artery Spasm - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009120 - Term: Muscle Cramp - ID: D000013035 - Term: Spasm - ID: D000003329 - Term: Coronary Vasospasm ### Intervention Browse Module - Ancestors - ID: D000000959 - Term: Antihypertensive Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1753 - Name: Bosentan - Relevance: HIGH - As Found: Urethral - ID: M30466 - Name: Endothelin Receptor Antagonists - Relevance: HIGH - As Found: ASP8062 - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077300 - Term: Bosentan - ID: D000065128 - Term: Endothelin Receptor Antagonists ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432439 **Brief Title:** Impact of Microneedling on Coverage of RT1 Gingival Recession in Thin Phenotype. **Official Title:** Microneedling And Its Effect On Outcome Of Root Coverage With Coronally Advanced Flap Involving Isolated RT1 Maxillary Gingival Recession In Thin Gingival Phenotype: A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** Amisha perio #### Organization **Class:** OTHER **Full Name:** Postgraduate Institute of Dental Sciences Rohtak ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Postgraduate Institute of Dental Sciences Rohtak #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Gingival Recession (GR) is a common finding in among adults, regardless of the oral hygiene levels. When it is associated with esthetic impairment, dentin hypersensitivity, root caries, surgical treatment is indicated. Mid-buccal Gingival Recessions are an extremely prevalent condition and have root coverage potential through periodontal plastic surgery procedures. A flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in Coronally Advanced Flap (CAF)procedure. The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by CAF procedures in thin gingival phenotype. **Detailed Description:** Gingival recession is defined as the migration of the marginal tissue toward the apical of the cementoenamel junction. It is one of the most common mucogingival deformities requiring surgical correction. The rationale for treating buccal recessions are mainly aesthetic concerns, and clinical situations where unfavourable contour of the gingival margin might be an obstacle for proper plaque control. Cairo et al in 2018 categorised GRs into 3 types with reference to interdental clinical attachment loss as RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap is a simple and predictable treatment of gingival recession defects. It has been observed that a flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in CAF procedure. Microneedling (MN), creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors are released. MN as opposed to Connective Tissue Grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the Gingival Thickness of individuals with thin gingival phenotype. ### Conditions Module **Conditions:** - Gingival Recession, Localized **Keywords:** - microneedling - phenotype - gingival recession - coronally advanced flap ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Isolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures **Intervention Names:** - Procedure: microneedling followed by CAF procedures **Label:** TEST GROUP **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Isolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone. **Intervention Names:** - Procedure: CAF procedure **Label:** CONTROL GROUP **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - TEST GROUP **Description:** microneedling will be done on gingiva of RT1 recession tooth in 4 sessions followed by CAF 2months later for root coverage **Name:** microneedling followed by CAF procedures **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - CONTROL GROUP **Description:** RT1 gingival recession coverage by CAF procedures alone. **Name:** CAF procedure **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region. **Measure:** Recession Depth **Time Frame:** 3 months **Description:** recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction. **Measure:** RECESSION WIDTH (RW) **Time Frame:** 3 months **Description:** calculated according to the formula Root Coverage percentage = Recession depth (preop-postop)\*100 Recession depth preoperative **Measure:** ROOT COVERAGE PERCENTAGE **Time Frame:** 3 months **Description:** GT is measured with the help of No:15 endodontic spreaders with silicon disc as stopper was inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue was felt. The depth of penetration was noted using digital calliper **Measure:** Gingival thickness(GT) **Time Frame:** 3 months #### Secondary Outcomes **Description:** Clinical attachment level will be measured as the distance between the cemento- enamel junction and the base of pocket. Measurements will be made at 6 sites of each tooth **Measure:** CLINICAL ATTACHMENT LEVEL (CAL) **Time Frame:** 3 months **Description:** Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. The probing depth measurements will be assessed using the Periodontal probe **Measure:** Probing Pocket Depth (PPD) **Time Frame:** 3 months **Description:** It will be measured by walking the periodontal probe at 6 sites of each tooth **Measure:** Bleeding on Probing (BOP) **Time Frame:** 3 months **Description:** For the scoring, a mouth mirror, an explorer and a light source will be used on air dried teeth and gingiva **Measure:** Plaque Index (PI) **Time Frame:** 3 months **Description:** Gingival index by Loe and Silness (1963)22 will be used to assess severity of gingival inflammation **Measure:** Gingival Index (GI **Time Frame:** 3 months **Description:** Keratinized tissue width will be measured with the help of UNC 15 probe with silicon stopper from the mucogingival junction to the free gingival margin and measured on vernier caliper **Measure:** Keratinized Tissue Width (KTW) **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** INCLUSION CRITERIA: * Presence of isolated (RT1) by Cairo et al 2011 buccal maxillary gingival recessions in esthetic zone including maxillary central incisors, lateral incisors and canines associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy. * Gingival Recession ≥2mm and clinically identifiable CEJ * Age 20years-50 years * Patient demonstrating compliance for maintaining good oral hygiene after Phase 1 thearpy Plaque index (PI) \<1, Gingival Index (GI) \<1 * Providing a written and verbal informed consent. EXCLUSION CRITERIA * Patient with systemic disease that can influence the outcome of therapy. * Pregnant females or on oral contraceptive pills or hormone replacement therapy. * Smokers and patients undergoing orthodontic therapy * Physically and mentally impaired patients. * Non vital, malpositioned tooth * Presence of cervical abrasions or restorations in the area * Previous history of periodontal surgery on the involved sites. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nishi Tanwar, MDS **Phone:** 8368126310 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Amisha Goyal, BDS **Phone:** 9718413637 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** PGIDS **Name:** Amisha Goyal, BDS **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000055093 - Term: Periodontal Atrophy ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9001 - Name: Gingival Recession - Relevance: HIGH - As Found: Gingival Recession - ID: M8994 - Name: Gingival Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M28025 - Name: Periodontal Atrophy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005889 - Term: Gingival Recession ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432426 **Brief Title:** Virtual Exercise on Elderly Breast Cancer Survivors **Official Title:** The Effect of Virtual Exercise on Elderly Breast Cancer Survivors on Functionality, Muscular Strength, and Quality of Life Effecto-B): #### Organization Study ID Info **ID:** 38330628 #### Organization **Class:** OTHER **Full Name:** Pontificia Universidad Catolica de Chile ### Status Module #### Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Pontificia Universidad Catolica de Chile #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Breast cancer (BC) is the most common neoplasia. Frequent for women and half of the new cases occur in people over 65 years of age. The treatment of BC generates adverse effects that deteriorate the physical functionality, muscle strength and quality of life of the survivors. This is more noticeable in elderly BC survivors. Physical exercise improves some adverse effects of BC, but few studies have focused on physical functionality, especially in older people. The elderly population reports the lowest adherence and lower level of physical activity. It is relevant to explore innovative and specific proposals for physical exercise for elderly survivors of BC. One solution may be virtual reality game-based exercise, which has been shown in healthy older people to significantly improve physical functionality and adherence compared to traditional physical exercise. The objective of our study is to estimate the feasibility and effect of a virtual reality-based exercise program on the functionality, muscle strength, and quality of life of older BC survivors, compared to a group undergoing traditional physical exercise. **Detailed Description:** This is a randomized controlled study. It will be conducted at the Dr. Sotero del Río Assistance Complex, which receives Southeast Metropolitan Health Service patients. Participants: 60 women over 60yrs who completed their antineoplastic treatment at least two years ago will be recruited. Functionality will be measured using the Short Physical Performance Battery (SPPB), which is specific for older individuals. Hydraulic Dynamometry (Jamar © hydraulic hand dynamometer) will evaluate isometric upper limb muscle strength. Quality of life shall be assessed using the EORTC QLQ C30 Quality of Life Questionnaire - with its EORTC QLQ-ELD14 module, validated in the Chilean population. Feasibility will be measured using recruitment rate (≥50%), retention rate (≥ 80%), adherence rate (75% of total sessions ≥14 sessions), and incidence of adverse events. Candidates will be randomly assigned to either virtual reality or traditional exercise groups. Both training groups will involve supervised sessions twice a week for nine weeks. The traditional exercise group exercises will be for arms and legs, involving body weight and external weights. Meanwhile, the virtual reality group will follow a physical exercise protocol using the "Nintendo Wii Fit" console. After the 9th week, participants will be evaluated one month after completing the training program. ### Conditions Module **Conditions:** - Breast Cancer **Keywords:** - breast neoplasm - elderly - physical exercise - virtual reality ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will undergo a postural balance rehabilitation program, utilizing a probed protocol for the elderly population with virtual reality via the Nintendo Wii Fit® and its peripheral Balance Board system. Supervised group sessions will be conducted twice a week for 9 weeks. **Intervention Names:** - Behavioral: Virtual reality training group **Label:** Virtual Reality Training Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will undergo a standardized physical exercise program based on a validated protocol designed for elderly breast cancer survivors **Intervention Names:** - Behavioral: Standard physical exercise group **Label:** Standard physical exercise Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Virtual Reality Training Group **Description:** Participants will be given virtual reality games on Nintendo Wii Fit® and its peripheral Balance Board system. This equipment offers safe and engaging training protocols. Additionally, it ensures physical exercise in the three planes of movement (sagittal, frontal, and transverse) and with three difficulty levels, thus providing a linear progressive demand. **Name:** Virtual reality training group **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Standard physical exercise Group **Description:** Participants will be submitted to a standard physical exercise program based on the ACSM guidelines. Resistance training will involve exercises for arms and legs, using bodyweight self-loading and external weights. Balance exercises will include the three planes of movement. **Name:** Standard physical exercise group **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Functionality will be measured by the Short Physical Performance Battery (SPPB). This battery is specific for older individuals and assess balance, walking speed, and lower extremity strength/endurance. It is a tool with moderate to excellent validity and excellent test-retest reliability (ICC=0.91). **Measure:** Change in the functionality **Time Frame:** Baseline, week 9 and week 13 #### Secondary Outcomes **Description:** Upper body muscle strength will be assessed by manual grip strength measured with a hydraulic dynamometer (Jamar© hydraulic hand dynamometer) in kilograms. It is considered the gold standard for quantitative and objective evaluation of isometric hand and forearm muscle strength. **Measure:** Change in upper limb muscle strength **Time Frame:** Baseline, week 9 and week 13 **Description:** Lower body muscle strength will be measured using the 30-second Chair Stand Test. It has excellent validity and reliability in older adults. It is measured in the number of repetitions. The number of times the person can stand up from the chair in 30 seconds is recorded. **Measure:** Change in lower limb muscle strength **Time Frame:** Baseline, week 9 and week 13 **Description:** Quality if life will be assessed with the QLQ C-30 questionnaire and the specific module QLQ-ELD14. The questionnaire could be self-administered and is validated to assess health-related quality of life in breast cancer patients. It has been validated in Spanish and in the Chilean population. Better quality of life is defined by a higher score (0-100) for global health status or overall quality of life. **Measure:** Change in the quality of life score **Time Frame:** Baseline, week 9 and week 13 **Description:** It will be measured by the recruitment rate (\>50%), retention rate (\>80%), adherence rate (75% of total sessions \>14 sessions), and the incidence of adverse effects. The measurements will be reported together as feasibility **Measure:** Feasibility assesment **Time Frame:** Baseline, week 1-9 and week 13 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women between 60 and 80 years old. * Diagnosis of primary breast carcinoma. * Treated with at least two of the following treatments: surgery, radiotherapy, chemotherapy, hormone therapy, biological therapy. * Minimum of 2 years and a maximum of 10 years after finishing treatments (surgery, chemotherapy, and radiotherapy). * Being able to walk at least 4 meters independently or with a cane as assistive technology Exclusion Criteria: * Stage IV breast cancer. * Previous cancer treatment for any type of cancer other than breast cancer (chemotherapy, radiotherapy, or endocrine therapy). * Cognitive impairment measured by the abbreviated Mini-Mental State Examination with a score \< 13 points. * Medical contraindication to perform physical exercise. * Self-reported of physical activity equivalent to the recent American College of Sports Medicine Exercise Guidelines for Cancer Patients and Survivors (150 min/week of moderate aerobic exercise and strength exercise twice a week). * Body mass index \< 18.5 kg/m2 or \> 40 kg/m2. **Maximum Age:** 80 Years **Minimum Age:** 60 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Karol Ramírez-Parada, PT **Phone:** 22 3541168 **Role:** CONTACT #### Locations **Location 1:** **City:** Santiago **Contacts:** ***Contact 1:*** - **Name:** Karol Ramírez-Parada - **Role:** CONTACT ***Contact 2:*** - **Name:** Scarlet Muñoz - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Karol Ramírez-Parada - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Chile **Facility:** Complejo Asistencial Dr. Sótero del Río **State:** Puente Alto **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Pontificia Universidad Catolica de Chile **Name:** Karol Ramírez-Parada, PT **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432413 **Brief Title:** Emerging Role of NOTCH-related Long Non-coding RNA(s) as Biomarkers in Liquid Biopsy From Colorectal Cancer Patients **Official Title:** Emerging Role of NOTCH-related Long Non-coding RNA(s) as Biomarkers in Liquid Biopsy From Colorectal Cancer Patients #### Organization Study ID Info **ID:** RHDIRB2020110301 REC #15 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2022-12-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-10-30 **Type:** ACTUAL #### Start Date **Date:** 2021-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This work aims to Investigate the role of circulating notch associated lncRNAs SNHG3 and LUNAR1 as possible non invasive prognostic biomarkers for colorectal cancer (CRC) monitoring via measuring the gene expression level of lncRNAs SNHG3 and LUNAR1 in serum of CRC patients compared with control subjects. Also, to investigate the correlation between SNHG3 and LUNAR1 expression levels and CRC clinicopathological features and their relevance for CRC patients' clinico-pathological features outcomes assessment **Detailed Description:** 1. INTRODUCTION Background: Colorectal cancer (CRC) has been identified as a major public health concern given its high incidence and mortality rates (1). In 2020, CRC was the third-most prevalent malignancy after breast and lung cancer, accounting for 10% of new cases and ranking second in terms of mortality with 9.4% of deaths (2). Unfortunately, by year 2030, more than 2.2 million new cases and 1.1 million fatalities from CRC are globally anticipated (3). Problem: Despite significant improvements in CRC surgical or radiological interventional treatment approaches with neo-adjuvant therapies, patients' prognosis remains bleak (4,5). Metastases and post-surgical tumor recurrence are prevalent, particularly, in more advanced cancer cases (6), which may account for the increased number of cases and fatalities prediction, being against the national efforts for achieving Egypt Vision 2030 implementing SDGs. Problem statement: Conventionally used CRC prognostic markers for monitoring treatment outcome and pointing to cancer recurrence are carbohydrate antigen 19.9 (CA19.9) and/or carcinoembryonic antigen (CEA) that are not that sensitive (7) per patients subclassification or stratification related to CRC pathological characteristics for more efficient and earlier prognosis. Thence, a growing demand for sensitive and precise bio-molecular marker(s) better correlating with CRC prognostic markers and/or CRC clinical outcome (8), that is if successful would constitute the bases for "Better Health" SDG#3 and less cancer recurrence and, therefore, less mortality. Liquid biopsies are used for cancer diagnosis or prognosis, like breast cancer, leukemia, liver cancer or CRC, via measurement of tumor-derived bio-molecular markers including circulating ncRNAs including long non-coding RNAs (lncRNAs), microRNA, exosomal ncRNAs, oncogenes or tumor suppressor genes, and their mutations, tumor-related-cytokines, and down-stream target proteins (9-22). After extensive literature search and mining to mind-the-research-gap(s) for better "Cancer Epigenetics Study; a Step-toward ncRNA-Precision" we have chosen, in the current work, two notch-related lncRNAs to study in relation-to-CRC prognosis. Notch-signaling pathway is an ubiquitous cascade within species to control a broad variety of biological events, including cell division, proliferation, and cell death (23,24). Recent investigations have revealed the fundamental role of Notch-cascade in CRC evolution (25). Intestinal epithelial cells' homeostatic self-renewal and tumor-promoting transformation can both be managed by Notch signaling (26). Stimulation of Notch-cascade can be epigenetically triggered by dysregulated non-protein coding RNAs' (ncRNAs) expressions (27); a hot area of research nowadays to figure out the impact of Notch-related ncRNAs on CRC risk and/or progression. The significant utility of tumor-expressed Notch-associated lncRNAs as prognostic malignancy indicators proves how they are connected to carcinogenesis or metastasis and therefore, reflect the outcome(s) in different cancer types including CRC (28-31). Small Nucleolar RNA Host Gene3 (SNHG3) is 4950bp lncRNA situated on chromosome 1p35.3 (32). In breast cancer, upregulated SNHG3 triggers Notch system activation as a result of its competitive binding to human homo sapiens (hsa) micro-RNA (miR) hsa-miR-154-3p exacerbating proliferation and metastasis of cancer cells (33). Moreover, SNHG3 positively regulates Notch1 expression in ovarian cancer through hsa-miR-139-5p suppression, accelerating tumor cells' proliferation and migration (34). SNHG3 exerted a carcinogenic role in prostate cancer, osteosarcoma, glioma, gastric cancer, laryngeal cancer, bladder cancer, and CRC (32). Huang et al. reported SNHG3 elevated expression in CRC cells and tissues, stimulating cancer progression through sponging hsa-miR-182-5p (35). Therefore, SNHG3 is considered as a malignancy enhancer that regulates Notch system in various cancer types. Leukemia-associated nc-insulin-like growth factor1 receptor (IGF1R)-Activator RNA1 (LUNAR1) serves as a downstream target of Notch-signaling, in the same time LUNAR1 acts through Notch-signaling stimulation. LUNAR1 is a transcript of 491 nucleotides (nt) gene on chromosome 15q26.3 with four exons and poly (A) tail (36). LUNAR1 was identified to be elevated in CRC tissues, triggered by Notch1 stimulation, accelerating CRC progression via retaining IGF1R expression (37), being a positive regulator of cell division Aim of the study: Per, few research publications on both notch-related lncRNAs, SNHG3 and LUNAR1, in CRC prognosis or CRC risk assessment as well as patients' stratification based on clinico-pathological characteristics, therefore, assessment of the clinical utility of SNHG3 and LUNAR1 lncRNAs fold change expressions in CRC patients' peripheral blood liquid biopsy is alarming (as step toward implementing ncRNA precision) Study objective(s) to assess, first, the expression level and pattern of Notch-associated lncRNAs SNHG3 and LUNAR1 in peripheral blood liquid biopsy, polled from treatment-naïve Egyptian CRC patients' cohort, compared to age-matched and sex-matched apparently healthy volunteer subjects as controls. Second, to evaluate lncRNAs SNHG3 and LUNAR1 expression usefulness as sensitive, non-invasive prognostic bio-molecular marker(s) for CRC monitoring. Third, to investigate the correlation between SNHG3 and LUNAR1 expression with CRC clinic-pathological features. Finally, to explore the relevance of the investigated lncRNAs for CRC patients' clinical features outcomes assessment. All these objectives to be confirmed or ruled out by in silico analysis and bioinformatics databases search SUBJECTS 2.1. Sample Size and Power of the Study. In accordance with prior reference studies (36,38) the sample size was estimated utilizing sample size online calculator https://riskcalc.org/samplesize/# for comparison of the area under the curve (AUC) with a null hypothesis value (done January, 2021) through using two-sided significance level of 0.05 and the power (1-beta) of 0.95 as the two-sided confidence level of 95%. Groups will be 45 samples for CRC patients and 17 controls for SNHG3 and 48 CRC patients' vs 16 controls for LUNAR1. 2.2. Study Design. Case-controlled, retrospective observational study. The study was carried out from June, 2021 to October, 2022. 2.3. Institutional Review Board (IRB) Statement: This study was ethically approved by the review board Research Ethical Committee (REC) of Faculty of Pharmacy, Ain Shams University (REC ID 15, 2021) that was approved by the Faculty of Medicine, Ain Shams University Hospitals, Ain Shams University REC. This research investigation was conducted out in compliance with Declaration of Helsinki principles World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects, 2013. Every volunteering participant in the study, whether apparently healthy controls or CRC patients, were fully aware of the study's objective and signed a written comprehensive informed consent (I.C) form (ethically-approved) were considered in. 2.4. Study Participants 2.4.1. Patients group. 70 CRC Egyptian patients, admitted to the Oncology Center of the Faculty of Medicine, Ain Shams University Hospitals (ASUH) or the Oncological Surgery Department of Dar-El-Shafa Hospital, before surgical treatment or CRC neo-adjuvant treatment, if they were eligible and agreed to participate (signed the I.C) were recruited in the research. Male-to-female was 30:40 with an age-range; minimum-maximum 24 -79 years. 2.4.2. Apparently healthy control group. 26 randomly-chosen, age-matched, and sex-matched healthy subjects served as the control group. Male-to-female was 9:17 and age range; minimum-maximum 35 -78 years. Control group subjects were chosen from those who came to visit hospital workers in the hospital or from blood donors at the ASUH Blood Donation Unit. None of the control group did take any medications or have any diseases upon questioner and blood samples was taken for CBC. 2.4.3. Inclusion and Exclusion Criteria Patients, came to the Oncology Center of ASUH or the Oncological Surgery Department of Dar-El-Shafa Hospital, who experienced a range of colonic symptoms, such as constipation, abdominal discomfort, rectal bleeding, and abrupt weight loss were included in the study when diagnosis of CRC was clinically confirmed by abdominal radiography, colonoscopy, and histopathology. Exclusion criteria patients who received chemotherapy, radiotherapy or undergone surgery. Patients with other types of cancer were also excluded. Individuals with missing data were not included. 2.4.4. Patients Pathological and Clinical Data For each CRC participant colonoscopy outcomes, abdominal radiographic imaging, pathological evaluations were used to define CRC staging. Tumor lymph-node metastasis (TNM) staging criteria was based on the American Joint Committee on Cancer (AJCC) (39) criterion. CRC study participants' family history, hypertension (HTN) or diabetes mellitus (DM) were recorded as non-communicable diseases (NCD), to correlate them to notch-related lncRNAs studied. Inflammatory conditions such as ulcerative colitis, tumor size, tumor location if rectal, colonic or rectosigmoid, being mucinous tumor or not, tumor invasion depth, lymph-node metastasis (LNM), presence of vascular invasion or not, tumor differentiation status; adenocarcinoma, moderately differentiated adenocarcinoma or poorly differentiated adenocarcinoma as well as the presence of the sub histologic features, signet ring cell, or not, were collected from eligible volunteering CRC patients' files. 3. Methods 3.1. In Silico Analysis 3.1.1. Notch-related lncRNA Bioinformatics from various databases via (accessed January, 2021 and revised July, 2023) Gene Set Enrichment Analysis (GSEA) (40) with ClusterProfiler utilizing the Kyoto Encyclopedia of Genes and Genomes (KEGG) (41,42) from Genome net https://www.genome.jp/ was used to analyze the functional enrichment of genes, diseases, networks, drugs, and pathways related to Notch-signaling. Ensemble database search (43) https://www.ensembl.org/index.html for the potential probable Notch-related lncRNAs SNHG3 and LUNAR1 genes National Center for Biotechnology Information (NCBI) https://www.ncbi.nlm.nih.gov/ search for characterization of the investigated hsa lncRNAs SNHG3 gene and transcripts (2) and hsa lncRNAs LUNAR1 gene and transcript (1). HUGO Gene Nomenclature Committee (HGNC) (44) https://www.genenames.org/ hsa lncRNAs genes SNHG3 and LUNAR1. 3.1.2. LncRNADisease v3.0 Expression LncRNA and Disease Database (version 3.0) (45) to explore the Notch-related lncRNAs expression CRC retrieved from validated experimental results in publications or predicted http://www.rnanut.net/lncrnadisease/index.php/home 3.1.3. Expression via ENCORI Project Pan-Cancer Analysis Platform (46) https://rnasysu.com/encori/panGeneDiffExp.php of lncRNA or genes across 32 types of Cancers. The expression box-plot values of genes from RNA-seq data were scaled with log2(FPKM + 0.01), while the ones from miRNA-seq data were scaled with log2(RPM + 0.01). Differential expression Analysis for SNHG3, LUNAR1 and its transcript IGF1R expression levels in CRC tumor samples vs control samples. 3.1.4. Functional Enrichment Analysis and Targeted Pathways KEGG Targeted Pathways and STRING Protein-Protein Interaction (PPI) Networks version 11.5 https://string-db.org/ (47,48) (Accessed on July, 2023). LncRNAWiki 2.0 LncRNA - LncRNAWiki - CNCB-NGDChttps://ngdc.cncb.ac.cn/lncrnawiki/ (Accessed August 30th, 2023) 3.2. Blood Samples From CRC patients and healthy volunteers, five milliliters of peripheral venous blood fluid biopsy were collected and stored in clot-activating polymer gel vacutainers (Greiner Bio-One GmbH, Australia). The samples were centrifuged in vacutainers at a speed of 4000 rpm for ten minutes at room temperature (25°C). The obtained serum was aliquoted and stored at -80°C in RNAse-free Eppendorf tubes. 3.2.1. Total RNA Extraction Using the miRNeasy Mini kit (Cat. No. 217004; Qiagen, Hilden, Germany), total RNA was isolated from sera in accordance with the protocol's instructions. Aliquots of the extracted RNA were kept at -80°C after being dissolved in 30 μl of RNase-free water. 3.2.2. Quantitation of purified RNA Using a NanoDrop®-1000 spectrophotometer (Thermo Scientific, Wilmington, DE, USA), the isolated RNA's purity and concentration are evaluated. RNA's quantity was determined in the sample utilizing absorbance at 260 nm (A260 = 1 → 44 ng/μl). In addition, the purity of RNA was evaluated utilizing A260/280 nm ratios. The acceptable 260/280 ratio ranges from 1.8 to 2.1, whereas the 260/230 ratio is more than 1.7. 3.2.3. Reverse Transcription Complementary DNA (cDNA) synthesis was carried out using the High-Capacity cDNA Reverse Transcription Kit with RNase Inhibitor (Cat. No 4374966, Applied Biosystems, ThermoFisher Scientific, USA) according to the manufacturer's regulations. In a 20 µl reaction volume, reverse transcription was carried out at 25 °C for 10 minutes, 37 °C for 120 minutes, and then underwent heat inactivation for 5 minutes at 85 °C. The produced cDNA was maintained at -80°C till further investigations. 3.2.4. Expression Measurement of lncRNAs Using Quantitative Real-Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) QRT-PCR was carried out in a 20 µl reaction using the TaqMan® Gene Expression Master Mix (Cat. No 4370048, Applied Biosystems, ThermoFisher Scientific, USA). In order to determine the expression levels of lncRNAs SNHG3 and LUNAR1, TaqMan gene expression assays for human SNHG3 (Hs05055352_s1, Cat. No 4448892, ThermoFisher Scientific, USA) and human LUNAR1 (Hs03829521_s1, Cat. No 4426961, ThermoFisher Scientific, USA) were used and the TaqMan gene expression assay for human glyceraldehyde 3-phosphate dehydrogenase (GAPDH) (Cat. No 4326317E, ThermoFisher Scientific, USA) was used as an endogenous standard to normalize the values. The reaction was conducted using the StepOne™ qRT-PCR technique (Applied Biosystems, CA, USA). The thermal cycling strategy was as follows: a stage of initial uracil-N-glycosylase (UNG) incubation at 50°C for 2 minutes, followed by activation step lasting 10 minutes at 95 °C proceeded by 40 cycles of denaturation for 15 sec at 95 °C, annealing and extending for 1 minute at 60 °C. Per the manufacturer, the assay "limit of detection" (LoD) can detect cDNA template from 1pg to 100 ng in nuclease free water. The cycle threshold (Ct) technique as a fold change (2-ΔΔCt) was used to calculate and normalize the lncRNAs expression levels, utilizing GAPDH as the housekeeping gene. ΔCt was obtained by subtracting the Ct values of GAPDH from either SNHG3 or LUNAR1 Ct values (49), where; ΔΔCt = ΔCtCRC samples - ΔCthealthy control samples 3.2.5. CEA and CA19-9 determination by electrochemiluminescence immunoassay One portion of the obtained sera was utilized for the purpose of determining CEA and CA19-9 tumor markers. Electrochemiluminescence immunoassay utilizing Cobas® e 602 developed by Roche Diagnostics, GmbH, Germany was used to determine the serum concentrations of CEA (Cat. No 11731629 322) and CA19.9 (Cat. No 11776193500), according to the manufacturer's protocol. 3.2.6. Routine biochemical testing results record from patients' files Liver function tests; aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) as well as serum creatinine and serum urea levels, hemoglobin (Hgb), platelet count, lymphocytes count, and prothrombin time (PT) were all gathered from patients' files. 3.2.7. Ratios and Indices In meters, participants' heights and in kilograms their weights were recorded, to calculate Body mass index (BMI in kg/m2) where overweight subjects have BMI of 25-29.9 kg/m2, 30 kg/m2 or over are obese, while 18.5-24.9 kg/m2 is indicative of normal weight, https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm The immune response-related inflammation indicator biomarker able to predict the accompanying inflammatory disorder severity is the platelet-to-lymphocytes ratio (PLR) (10,50). 3.3. Statistical Analysis With the aid of GraphPad Prism® version 9.01 (GraphPad Software, San Diego, CA, USA, SPSS 23.0 (statistical package for social studies software) (IBM, Armonk, NY), MedCalc Statistic Software version 19.1 (MedCalc Software by Ostend, Belgium), and Microsoft Office Excel 2019, statistical analysis was carried out. Chi-square test (χ2) was utilized to assess the associations between participants' characteristics and the groups. The Shapiro-Wilk normality test as well as Kolmogorov-Smirnov test were applied to determine the pattern of the normal distribution for the both groups and subgroups of data. Data was expressed as mean ±SD when it passed the normality test. Student's (t) test was utilized to determine any significant differences between two normally distributed groups. Additionally, one-way ANOVA (F) followed by post hoc Tukey's multiple comparison test was used, when required, to determine significant variations between multiple groups. While, the data that didn't pass the normality test was expressed as median (interquartile range) (IQR) (25th percentile-75th percentile). The Mann-Whitney (U) test was used to pinpoint the significant changes between two sets of participants. Moreover, the Kruskal-Wallis (H) test and consequently Dunn's multiple comparison test were used, when needed, to determine whether there were statistically significant differences between different groups. The receiver operating characteristic (ROC) curve as well as AUC were implemented to evaluate the abilities of serum lncRNAs SNHG3 and LUNAR1 for discrimination between groups and with groups for subgrouping identification. The best cut-off, sensitivities (SNs), specificities (SPs) as well as negative and positive predictive values NPVs and PPVs, respectively, were all determined using the ROC curve, with AUC estimated range from 0 to 1. Negative likelihood ratios (LRs) are employed in medical testing to evaluate the marker discriminative efficiency. The ratio, which denotes the likelihood that a person has the disease or condition, confirms the SNs and SPs identified by the ROC curve. SN and SP provide a different meaning for the LR, with negative LR equal to (100-SN)/SP. Multiple regression models were used to assess the influence of the participants demographic and patients' clinicopathological data (as independent factors) on the expression levels of the lncRNAs SNHG3 and LUNAR1 that we considered as the dependent variables. Correlation between numerous variables was assessed using Spearman's correlation coefficient (r). Statistical analysis tests are set significant when the two-tailed p-value is \<0.05 (\*). ### Conditions Module **Conditions:** - Colorectal Cancer **Keywords:** - Notch; SNHG3; LUNAR1; lncRNAs; colorectal cancer; prognosis; epigenetics ### Design Module #### Bio Spec **Description:** five milliliters of peripheral venous blood fluid biopsy were collected and stored in clot-activating polymer gel vacutainers (Greiner Bio-One GmbH, Australia). The samples were centrifuged in vacutainers at a speed of 4000 rpm for ten minutes at room temperature (25°C). The obtained serum was aliquoted and stored at -80°C in RNAse-free Eppendorf tubes. Using the miRNeasy Mini kit (Cat. No. 217004; Qiagen, Hilden, Germany), total RNA was isolated from sera in accordance with the protocol's instructions. Aliquots of the extracted RNA were kept at -80°C after being dissolved in 30 μl of RNase-free water. **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 96 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 70 CRC Egyptian patients, admitted to the Oncology Center of the Faculty of Medicine, Ain Shams University Hospitals or the Oncological Surgery Department of Dar-El-Shafa Hospital, before surgical treatment or CRC neo-adjuvant treatment, if they were eligible and agreed to participate (signed the Informed consent) were recruited in the research. **Label:** Patients group #### Arm Group 2 **Description:** 26 randomly-chosen, age-matched, and sex-matched healthy subjects served as the control group. Control group subjects were chosen from those who came to visit hospital workers in the hospital or from blood donors at the ASUH Blood Donation Unit. None of the control group did take any medications or have any diseases upon questioner and blood samples was taken for CBC. **Label:** Apparently healthy control group ### Outcomes Module #### Primary Outcomes **Description:** the expression level and pattern of Notch-associated lncRNAs SNHG3 and LUNAR1 in peripheral blood liquid biopsy, polled from treatment-naïve Egyptian CRC patients' cohort, compared to age-matched and sex-matched apparently healthy volunteer subjects as controls. **Measure:** measure the expression level and pattern of Notch-associated lncRNAs SNHG3 and LUNAR1 in peripheral blood liquid biopsy in relation to clinico-pathological tumor features. **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients, came to the Oncology Center of ASUH or the Oncological Surgery Department of Dar-El-Shafa Hospital, who experienced a range of colonic symptoms, such as constipation, ab-dominal discomfort, rectal bleeding, and abrupt weight loss were included in the study when di-agnosis of CRC was clinically confirmed by abdominal radiography, colonoscopy, and histo-pathology. Exclusion Criteria: * patients who received chemotherapy, radiotherapy or undergone surgery. Patients with other types of cancer were also excluded. Individuals with missing data were not included. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** for Patients group. CRC Egyptian patients, who admitted to the Oncology Center of the Faculty of Medicine, Ain Shams University Hospitals (ASUH) or the Oncological Surgery Department of Dar-El-Shafa Hospital, before surgical treatment or CRC neo-adjuvant treatment, if they were eligible and agreed to participate (signed the I.C) were recruited in the research. Apparently healthy control group. randomly-chosen, age-matched, and sex-matched healthy subjects served as the control group. Control group subjects were chosen from those who came to visit hospital workers in the hospital or from blood donors at the ASUH Blood Donation Unit. None of the control group did take any medications or have any diseases upon questioner and blood samples was taken for CBC. ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of Pharmacy, Ain Shams University, AdvancedBiochemistry Research Lab **Zip:** 11566 #### Overall Officials **Official 1:** **Affiliation:** Faculty of pharmacy Ain Shams University **Name:** Nadia Hamdy, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432400 **Acronym:** IRTIPAP **Brief Title:** Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders **Official Title:** Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders Followed up in the Medical and Psychological Centre: Multicentre Descriptive Study #### Organization Study ID Info **ID:** CHRD0824 #### Organization **Class:** OTHER **Full Name:** Hôpital NOVO #### Secondary ID Infos **Domain:** ANSM **ID:** 2024-A00790-47 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hôpital NOVO #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery. **Detailed Description:** Between 61% and 81% of men and 51% to 74% of women are exposed to a traumatic event in their lifetime. These events may be brief and discrete, prolonged and/or recurrent, and may be direct or indirect. Direct or indirect exposure to traumatic events can lead to serious negative psychological consequences, including post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD). People exposed to complex traumatic events are at risk not only of suffering from PTSD or Complex PTSD, but also from other mental health co-morbidities, such as substance use disorders (drugs, alcohol, benzodiazepine misuse) , often associated with the repetition of situations of interpersonal violence from which it is difficult, if not impossible, to escape. Caring for people suffering from psychological trauma is a major public health issue. However, there are no good clinical practice guidelines for diagnosis, assessment and treatment, which would enable good practice to be standardised and disseminated. The prevention, detection, early support and appropriate guidance of people suffering from post-traumatic sequelae promote their recovery and improve their quality of life. The World Health Organization (WHO) refers to this as psychological distress, and points out that if it is not properly identified or accompanied, it can tip a person into illness or increase social difficulties. When it is temporary and follows a stressful event, it is considered a normal adaptive reaction. On the other hand, when it becomes intense and persistent, it may be an indicator of a psychological disorder. The public health challenge associated with PTSD is to better recognise, diagnose and treat it, as it can have serious consequences for the quality of life, social functioning and suicide risk of those affected. The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery. It would also make it possible to provide individualised support for patients and improve their quality of life. ### Conditions Module **Conditions:** - Post Traumatic Stress Disorder **Keywords:** - Post Traumatic Stress Disorder - Complex post traumatic stress disorder - Medical and Psychological Centre ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group composed of patients suffering from disorders related to the use of alcohol, cannabis, opiates, inhalants, sedatives, hypnotics, anxiolytics, stimulants, hallucinogens (all of these disorders will have been diagnosed by a doctor before or during follow-up according to Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM 5) criteria) **Intervention Names:** - Other: Patient questionnaires **Label:** Substance use disorders **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Substance use disorders **Description:** Patients questionnaires, on paper and data collection on patients medical file **Name:** Patient questionnaires **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Percentage of patients with PTSD among those with substance use disorders Patients with PTSD will be identified using the International Trauma Questionnaire (ITQ) : A diagnosis of PTSD requires the presence of at least one symptom in each of the following dimensions * P1 or P2 ≥ 2 * P3 or P4 ≥ 2 * 5 or P6 ≥ 2 AND * P7 or P8 or P9 ≥ 2 Score ITQ for PTSD : ≥ 8 **Measure:** Assessment of the proportion of Post-Traumatic Stress Disorder (PTSD) in patients with substance use disorders **Time Frame:** At the end of the study, an average of 12 month #### Secondary Outcomes **Description:** Percentage of patients with CPTSD among those with substance use disorders Patients with CPTSD will be identified using the International Trauma Questionnaire (ITQ) : A diagnosis of CPTSD requires a PTSD : ≥ 8 and, at least, one symptom in each of the dimensions of disturbance of self-organisation * C1 or C2 ≥ 2 * C3 or C4 ≥ 2 * C5 or C6 ≥ 2 AND * C7 or C8 or C9 ≥ 2 Score ITQ for CPTSD : ≥ 16 **Measure:** Distinguishing between the prevalence of Post-Traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD) **Time Frame:** At the end of the study, an average of 12 month **Description:** Risk factors will be identified from the demographic data collected via the patient characteristics questionnaire between PTSD and CPTSD patients **Measure:** Identification of risk factors by comparing demographic data of PTSD versus CPTSD patients **Time Frame:** At the end of the study, an average of 12 month **Description:** The pathologies most frequently associated with PTSD and CPTSD will be identified by collecting the pathologies present in the medical records of all patients. **Measure:** Identification of the pathologies most associated with PTSD and CPTSD **Time Frame:** At the end of the study, an average of 12 month **Description:** Comparison for number of days between the start of treatment for substance use disorders and the identification of PTSD or CPTSD **Measure:** Comparison of the time between management and identification of patients with PTSD versus CPTSD **Time Frame:** At the end of the study, an average of 12 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria : * Patient aged 18 or over * Patient followed up at the adult Medical and Psychological Centre in the centres taking part in the study * Patient suffering from disorders related to the use of alcohol, cannabis, opiates, inhalants, sedatives, hypnotics, anxiolytics, stimulants, hallucinogens (all of these disorders will have been diagnosed by a doctor before or during follow-up according to DSM 5 criteria). * Patient aware of their substance use disorders * Patient informed and did not object to participating in the study Exclusion Criteria : * Patient previously diagnosed with PTSD or CPTSD * Patient agitated and/or aggressive * Patient under guardianship/curators * Patient who do not speak or understand French **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Maryline DELATTRE **Phone:** +3333130754131 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Véronique DA COSTA **Phone:** +3333130755069 **Role:** CONTACT #### Locations **Location 1:** **City:** Beaumont-sur-Oise **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Benjamin Schmidt - **Phone:** +33 1 39 37 15 20 - **Role:** CONTACT **Country:** France **Facility:** Medical and Psychological Centre - Novo Hospital - Site Beaumont-sur-Oise **Zip:** 95260 **Location 2:** **City:** Clermont **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Deborah DELABY - **Phone:** +33 6 09 62 50 12 - **Role:** CONTACT **Country:** France **Facility:** Medical and Psychological Centre - Isarien Hospital Centre **Zip:** 60600 #### Overall Officials **Official 1:** **Affiliation:** Isarien Hospital Centre **Name:** Déborah DELABY **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000064419 - Term: Chemically-Induced Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: HIGH - As Found: Traumatic Stress Disorder - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Post Traumatic Stress Disorder - ID: M21837 - Name: Substance-Related Disorders - Relevance: HIGH - As Found: Substance Use Disorders - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019966 - Term: Substance-Related Disorders - ID: D000040921 - Term: Stress Disorders, Traumatic - ID: D000013313 - Term: Stress Disorders, Post-Traumatic ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M9305 - Name: Hallucinogens - Relevance: LOW - As Found: Unknown - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M16905 - Name: Anti-Anxiety Agents - Relevance: LOW - As Found: Unknown - ID: M27371 - Name: Opiate Alkaloids - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432387 **Acronym:** CoFA-TAAA **Brief Title:** Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair **Official Title:** Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair (CoFA-TAAA); a Prospective Observational Study #### Organization Study ID Info **ID:** CoFA-TAAA #### Organization **Class:** OTHER **Full Name:** University of Thessaly ### Status Module #### Completion Date **Date:** 2026-01-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Thessaly #### Responsible Party **Investigator Affiliation:** University of Thessaly **Investigator Full Name:** Elena Arnaoutoglou **Investigator Title:** Professor of Anaesthesiology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will evaluate the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair. **Detailed Description:** Endovascular aneurysm repair of abdominal aorta activates a significant inflammation reaction and has an impact on coagulation. Platelet activation seems to have a major role in this prothrombotic and hypercoagulable state. In complex thoraco-abdominal aortic aneurysm repair the implants are more complexed and the duration of operation longer. The main hypothesis is that all the above have a greater impact on platelet activation and coagulation alterations. The aim of this study is the evaluation of the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair. ### Conditions Module **Conditions:** - Thoraco-abdominal Aortic Aneurysm Repair - Coagulation Factors Alterations - Platelet Activation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 58 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Perioperative laboratory examinations will follow institutional guidelines. These will include, but will not be limited to full blood count, conventional coagulation tests, liver function, and kidney function tests. Moreover, for the purpose of this study, the following parameters will also be obtained; vWF, factors VIII and XI, D-dimers, fibrinogen, platelets activation (multiplate), adams-13, anti-Xa and high sensitivity troponin. All samples will be obtained via puncture from a peripheral vein. Blood samples will obtained at three time points; preoperatively before induction to GA (01), postoperative day 1 (02) and postoperative day 3rd-4th (03). During hospitalization any myocardial injury after non cardiac surgery, acute kidney injure and post-implantation syndrome will be recorded. Of note, at 30 days, 3, 6 and 12 months our patients will undergo an evaluation for any major cardiovascular event, implant failure or death of any cause. **Intervention Names:** - Other: Patients undergoing complex thoraco-abdominal aortic aneurysm repair **Label:** Patients undergoing complex thoraco-abdominal aortic aneurysm repair ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients undergoing complex thoraco-abdominal aortic aneurysm repair **Description:** Patients undergoing complex thoraco-abdominal aortic aneurysm repair **Name:** Patients undergoing complex thoraco-abdominal aortic aneurysm repair **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Early preoperatively, early and late postoperatively **Measure:** Coagulation status **Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day **Measure:** Myocardial injury after non cardiac surgery **Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day **Measure:** Acute kidney injury **Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day **Measure:** Post-implantation syndrome **Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day **Measure:** Major cardiovascular events **Time Frame:** Day of surgery, 1st postoperative day, 4-5th postoperative day **Measure:** Major cardiovascular events, implant failure and death of any cause **Time Frame:** 30 days, 3, 6, and 12 months postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Consecutive patients undergoing complex thoraco-abdominal aortic aneurysm repair in University Hospital of Larissa, after informed consent will be included. Exclusion Criteria: * Refuse to participate * Prior surgery within 3 months * ASA PS \> 3 * Known medical history of thrombophilia or functional platelet dysfunction **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients will be treated by the same medical team in UHL according to the European Society for Vascular Surgery (ESVS) guidelines. Preoperatively patients will be treated with aspirin 100 mg once daily for at least 5 days. Postoperatively in the absence of bleeding patients will receive aspirin 100 mg and in the absence of neurological dysfunction due to spine ischemia they will receive clopidogrel 150 mg and from the next day dual antiplatelet therapy (aspirin 100 mg and clopidogrel 75 mg). If the patient was treated with anticoagulant agents this will be discontinued preoperative according to ACCP guidelines and it will be restarted on the 1st or 2nd postoperative day based on hemostasis. In this case patients will be treated with aspirin 100 mg once daily five days preoperatively and aspirin will also be continued postoperatively. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eleni Arnaoutoglou, Prof **Phone:** 6974301352 **Phone Ext:** +30 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Maria Ntalouka **Role:** CONTACT #### Locations **Location 1:** **City:** Larissa **Country:** Greece **Facility:** University of Thessaly **Zip:** 41335 #### Overall Officials **Official 1:** **Affiliation:** University of Thessaly **Name:** Eleni Arnaoutoglou, Prof **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001018 - Term: Aortic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4113 - Name: Aneurysm - Relevance: HIGH - As Found: Aneurysm - ID: M4330 - Name: Aortic Aneurysm - Relevance: HIGH - As Found: Aortic Aneurysm - ID: M19800 - Name: Aortic Aneurysm, Abdominal - Relevance: HIGH - As Found: Abdominal Aortic Aneurysm - ID: M3070 - Name: Aortic Aneurysm, Thoracoabdominal - Relevance: HIGH - As Found: Thoraco-Abdominal Aortic Aneurysm - ID: M19801 - Name: Aortic Aneurysm, Thoracic - Relevance: HIGH - As Found: Thoraco-Abdominal Aortic Aneurysm - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M4334 - Name: Aortic Diseases - Relevance: LOW - As Found: Unknown - ID: T66 - Name: Abdominal Aortic Aneurysm - Relevance: HIGH - As Found: Abdominal Aortic Aneurysm ### Condition Browse Module - Meshes - ID: D000000783 - Term: Aneurysm - ID: D000001014 - Term: Aortic Aneurysm - ID: D000017544 - Term: Aortic Aneurysm, Abdominal - ID: D000094624 - Term: Aortic Aneurysm, Thoracoabdominal - ID: D000017545 - Term: Aortic Aneurysm, Thoracic ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: Coag - Name: Coagulants ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M9581 - Name: Heparin, Low-Molecular-Weight - Relevance: LOW - As Found: Unknown - ID: M20153 - Name: Dalteparin - Relevance: LOW - As Found: Unknown - ID: M203832 - Name: Fibrin fragment D - Relevance: LOW - As Found: Unknown - ID: M8312 - Name: Factor VIII - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432374 **Brief Title:** Written Exposure Therapy for Nurses **Official Title:** Open Pilot of Written Exposure Therapy for Nurses Experiencing Work-Related Posttraumatic Stress #### Organization Study ID Info **ID:** HUM00203166 #### Organization **Class:** OTHER **Full Name:** University of Texas at Austin ### Status Module #### Completion Date **Date:** 2023-09-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-03-01 **Type:** ACTUAL #### Start Date **Date:** 2022-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Michigan #### Lead Sponsor **Class:** OTHER **Name:** University of Texas at Austin #### Responsible Party **Investigator Affiliation:** University of Texas at Austin **Investigator Full Name:** Yang Li **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Nurses often experience elevated levels of stress, overwork, and trauma in the workplace, leading to posttraumatic stress disorder (PTSD), depression, burnout, and even nurse turnover. While effective therapies for PTSD exist, barriers to treatment arise from nursing culture, such as workplace stigma about mental health problems, fear that psychological status may impact performance evaluations, and demands of shiftwork. There is a pressing need for scalable evidence-based interventions tailored to nursing culture to effectively address PTSD and related mental health issues. The study aimed to assess the feasibility, safety, and acceptability of a tailored evidence-based treatment, Written Exposure Therapy (WET), for nurses experiencing work-related traumatic stress. This single-arm open pilot study with pre- and post-intervention assessments, included participants from two nursing schools' alumni. Eligibility criteria included nurses screening positive for work-related trauma with a report of at least two PTSD symptoms. Participants engaged in a self-administered, asynchronous, five-week online writing session, facilitated by WET-trained nurses. Outcomes measures (PTSD, depression, anxiety, burnout, and intention to quit) were assessed at baseline, post-intervention, and 5-weeks follow-up. ### Conditions Module **Conditions:** - Posttraumatic Stress Disorder - Depressive Symptoms - Burn Out - Anxiety - Work Related Stress **Keywords:** - Nurses - Written Exposure Therapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** WET is a trauma-focused therapy for PTSD. It includes five writing sessions. **Intervention Names:** - Behavioral: WET **Label:** Written Exposure Therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Written Exposure Therapy **Description:** The five weekly WET sessions were delivered online via Canvas. Five session modules were created, each containing writing instructions for the respective session and an assignment feature for participants to upload their narratives. All sessions included 30 minutes of writing. Following instructions, participants wrote about a specific work-related trauma event in detail and described the emotions and thoughts experienced during the event. While all sessions were self-paced, participants were advised to complete each subsequent session within one week. Participants had the option to self-administer sessions or participate in Zoom "office hours" for live writing sessions with a facilitator who had completed WET training providing the writing instructions. **Name:** WET **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The PTSD Checklist for DSM-5 was used to assess symptoms of posttraumatic stress disorder in the past month. The total score ranges from 0-80, with higher scores indicating more severe PTSD symptoms. **Measure:** Posttraumatic stress disorder **Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up #### Secondary Outcomes **Description:** The Patient Health Questionnaire-8 was used to assess the frequency of depressed mood in the past two weeks. The total score ranges from 0-24, with higher scores indicating more severe depression symptoms. **Measure:** Depression **Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up **Description:** The Generalized Anxiety Disorder-7 was used to assess the frequency of anxiety symptoms in the past two weeks. The total score ranges from 0-21, with higher scores indicating more severe anxiety symptoms. **Measure:** Anxiety **Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up **Description:** The Professional Quality of Life was used to assess compassion satisfaction, burnout, and secondary traumatic stress. Each subscale score ranges from 10-50, with higher scores indicating higher levels of compassion satisfaction, more burnout symptoms, and more secondary traumatic stress. **Measure:** Professional Quality of Life **Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up **Description:** Intention to quit the job or leave the nursing profession were asked using two questions - "How often have you thought about quitting your job in the past month?", "How often have you thought about leaving the nursing profession in the past month?". The five responses are "never," "rarely," "sometimes," "very often", and "always." The scores for both intention to quit the job and intention to leave the nursing profession range from 1-5, with higher scores indicating greater intention to quit the job or leave the nursing profession. **Measure:** Intention to Quit **Time Frame:** Baseline, immediately post-intervention, and 5 weeks follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Work-related trauma * Posttraumatic stress disorder Exclusion Criteria: * Current substance abuse * Current suicidality * Current psychiatric treatment with psychotherapy or psychotropic medications other than selective serotonin (and norepinephrine) reuptake inhibitors (SSRI/SNRI). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ann Arbor **Country:** United States **Facility:** University of Michigan **State:** Michigan **Zip:** 48104 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000040921 - Term: Stress Disorders, Traumatic - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000001526 - Term: Behavioral Symptoms - ID: D000009784 - Term: Occupational Diseases - ID: D000013315 - Term: Stress, Psychological ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC24 - Name: Occupational Diseases ### Condition Browse Module - Browse Leaves - ID: M5326 - Name: Burns - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: LOW - As Found: Unknown - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Posttraumatic Stress Disorder - ID: M1167 - Name: Occupational Stress - Relevance: HIGH - As Found: Work Related Stress - ID: M1658 - Name: Burnout, Psychological - Relevance: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depressive Symptoms - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M12719 - Name: Occupational Diseases - Relevance: LOW - As Found: Unknown - ID: M16105 - Name: Stress, Psychological - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000073397 - Term: Occupational Stress - ID: D000013313 - Term: Stress Disorders, Post-Traumatic - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432361 **Brief Title:** Resource Allocation for Alcohol **Official Title:** Resource Allocation for Alcohol #### Organization Study ID Info **ID:** STUDY00018018 #### Organization **Class:** OTHER **Full Name:** University of Washington #### Secondary ID Infos **ID:** 1R34AA029478-01A1 **Link:** https://reporter.nih.gov/quickSearch/1R34AA029478-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2025-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Alcohol Abuse and Alcoholism (NIAAA) #### Lead Sponsor **Class:** OTHER **Name:** University of Washington #### Responsible Party **Investigator Affiliation:** University of Washington **Investigator Full Name:** Jennifer Cadigan **Investigator Title:** Assistant Professor, Department of Psychiatry and Behavioral Sciences **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A total of 150 young adults (ages 21-29) will be randomized to receive a brief alcohol intervention (intended to reduce alcohol-related resource allocation (e.g., time and money spent on alcohol), alcohol consumption, and alcohol related consequences) or an assessment only control condition. All participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Those in the intervention condition will receive weekly personalized information summarizing the previous week's resource allocation. All participants will complete a 1 and 3 month follow up survey. Participants can earn up to $126 for completing all study components. ### Conditions Module **Conditions:** - Alcohol Drinking ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains during the time, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Each daily survey should take no longer than 5 minutes to complete. Those in the intervention condition will receive weekly personalized information summarizing the previous week's resource allocation (e.g., personalized information on how they spent their time and money) in relation to their personal goals, interests, and alcohol use. They will also see a summary of how they spent their time and money in relation to their set goals for the week. The information in the intervention feedback will be obtained from participant's responses to the daily surveys on how they spent their time and money each day. Reviewing the intervention feedback should take no longer than 10 minutes. **Intervention Names:** - Behavioral: Resource Allocation **Label:** Resource Allocation Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains during the time, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Each daily survey should take no longer than 5 minutes to complete. **Intervention Names:** - Other: assessment only control **Label:** Assessment only control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Resource Allocation Intervention **Description:** Those in the intervention condition will receive weekly personalized information summarizing the previous week's resource allocation (e.g., personalized information on how they spent their time and money) in relation to their personal goals, interests, and alcohol use. They will also see a summary of how they spent their time and money in relation to their set goals for the week The information in the intervention feedback will be obtained from participant's responses to the daily surveys on how they spent their time and money each day. Reviewing the intervention feedback should take no longer than 10 minutes. **Name:** Resource Allocation **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Assessment only control **Description:** participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains during the time, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Each daily survey should take no longer than 5 minutes to complete. **Name:** assessment only control **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** We will assess the number of standard drinks, containing alcohol in a typical week collected on the Daily Drinking Questionnaire DDQ; Collins et al., 1985; Kivlahan et al., 1990) **Measure:** Standard drinks containing alcohol- **Time Frame:** past 1 month **Description:** We will assess the number of alcohol-related consequences experienced using the Rutgers Alcohol Problem Index. **Measure:** Alcohol-related problems **Time Frame:** past 1 month **Description:** Alcohol demand will be assessed with the Alcohol Purchase Task. **Measure:** Alcohol Demand **Time Frame:** past 1 month **Description:** Time allocation will be assessed (Murphy et al.,2012) where participants will indicate, on average, how many hours they spend in a typical week in various domains including alcohol-related domains. **Measure:** Time allocation **Time Frame:** past 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1)21-29 years old, 2) reside within WA state, 3) report drinking 2+ days per week, on average, in the last six months, 4) report 4+ heavy drinking episodes (4+/5+ for women/men) in the past month, Exclusion Criteria: * 1) currently enrolled in a 4-year college, 2) currently in or seeking treatment for alcohol use **Healthy Volunteers:** True **Maximum Age:** 29 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jennifer Cadigan, PhD **Phone:** 206-543-5689 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Washington **Name:** Jennifer Cadigan, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004327 - Term: Drinking Behavior ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3774 - Name: Alcohol Drinking - Relevance: HIGH - As Found: Alcohol Drinking - ID: M7502 - Name: Drinking Behavior - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000428 - Term: Alcohol Drinking ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432348 **Brief Title:** Pilates Exercises and Soccer: A Comparative Study of Mat vs. Reformer on FMS and ROM **Official Title:** Pilates Exercises and Soccer: A Comparative Study of Mat vs. Reformer on FMS and ROM #### Organization Study ID Info **ID:** OsmaniyeKAU Osman Yılmaz #### Organization **Class:** OTHER **Full Name:** Osmaniye Korkut Ata University ### Status Module #### Completion Date **Date:** 2022-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-04-30 **Type:** ACTUAL #### Start Date **Date:** 2021-11-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Osmaniye Korkut Ata University #### Responsible Party **Investigator Affiliation:** Osmaniye Korkut Ata University **Investigator Full Name:** Osman Yılmaz **Investigator Title:** PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Pilates exercises have been used to improve core strength, trunk and shoulder strength, lower body strength, agility, dynamic balance, coordination skills, flexibility, and posture in various sports. A previous study demonstrated the beneficial impact of mat Pilates exercises on the functional performance of soccer players. However, more research is needed to understand the effects of Pilates on the FMS and ROM. Consequently, this study aimed to investigate and compare the influence of mat Pilates and reformer Pilates exercises on FMS and ROM in soccer players, addressing this critical research gap. ### Conditions Module **Conditions:** - Sports, Mechanical **Keywords:** - Functional movement screening - Mat pilates - Reformer pilates - Range of motion ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Before starting the exercises, a 5-minute warm-up session was performed. The reformer Pilates exercise program included movements such as the Footwork Series (Toes, Heels, Tendon Stretch, V Position), Supine Arm Series (Pull, Circle, Pull Head Up, Triceps Press), Short Box Series (Round, Flat Back, Twist), Short Box and Arm Series (Chest Fly, The Gift, Rhomboid, Biceps Curl, Rowing, Triceps), Long Box Series (Swan, Pulling Fly), Stomach Massage (Round, Twist), Knee Stretch (Round, Flat Back), Hip Work Series (Double Leg Press, Hamstring Pulls, Leg Circle, Frog), Elephant, and Side Stretch. Participants had two-minute rest intervals after the Supine Arm Series, Short Box, Arm Series, and Knee Stretch movements. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks. **Intervention Names:** - Other: Reformer pilates **Label:** Reformer Pilates **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Before the exercises, a 5-minute warm-up session was performed. The mat Pilates exercise program included movements such as Rol Up, One Leg Circle, Double Leg Straight Lower, One Leg Stretch, Criss Cross, Toe Top, Shoulder Bridge, Seated Tracking, Spine Twist, Up-Down Side Kick, Front-Back Side Kick, Circle Side Kick, Flight, Swan, Rest Position, Swimming, Push Up, Long Stretch, Cat Cow, Mermaid Stretch. The participants had two-minute rest breaks after the toe-top, spine twist, and circle side-kick movements. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks. **Intervention Names:** - Other: Mat Pilates **Label:** Mat Pilates **Type:** EXPERIMENTAL #### Arm Group 3 **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Reformer Pilates **Description:** Before starting the exercises, a 5-minute warm-up session was performed. The reformer Pilates exercise program included movements such as the Footwork Series (Toes, Heels, Tendon Stretch, V Position), Supine Arm Series (Pull, Circle, Pull Head Up, Triceps Press), Short Box Series (Round, Flat Back, Twist), Short Box and Arm Series (Chest Fly, The Gift, Rhomboid, Biceps Curl, Rowing, Triceps), Long Box Series (Swan, Pulling Fly), Stomach Massage (Round, Twist), Knee Stretch (Round, Flat Back), Hip Work Series (Double Leg Press, Hamstring Pulls, Leg Circle, Frog), Elephant, and Side Stretch. Participants had two-minute rest intervals after the Supine Arm Series, Short Box, Arm Series, and Knee Stretch movements. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks. The participants underwent six weekly training sessions over eight weeks, comprising three Reformer Pilates sessions and three team training days. **Name:** Reformer pilates **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Mat Pilates **Description:** Before the exercises, a 5-minute warm-up session was performed. The mat Pilates exercise program included movements such as Rol Up, One Leg Circle, Double Leg Straight Lower, One Leg Stretch, Criss Cross, Toe Top, Shoulder Bridge, Seated Tracking, Spine Twist, Up-Down Side Kick, Front-Back Side Kick, Circle Side Kick, Flight, Swan, Rest Position, Swimming, Push Up, Long Stretch, Cat Cow, Mermaid Stretch. The participants had two-minute rest breaks after the toe-top, spine twist, and circle side-kick movements. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks. Movements were performed with ten repetitions in the first four weeks and 12 repetitions in the following four weeks. The participants underwent six weekly training sessions over eight weeks, comprising three Mat Pilates sessions and three team training days. **Name:** Mat Pilates **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Thirty voluntary participants were randomly assigned to either RP (n=10; mean age = 20.60 ± 1.65), MP (n=10; mean age = 19.40 ± 1.35), or CG (n=10; mean age = 20.10 ± 1.15). The Functional Movement Screening Test Kit was used in this study. It consists of seven movements: Deep Squat, Hurdle Step, In-Line Lunge, Shoulder Mobility, Active Straight Leg Raise, Trunk Stability Push-Up, and Rotary Stability. Each test was scored on a scale ranging from 0 to 3, with the highest possible score being 21 . Based on previous research, participants with a total FMS score lower than 14 were considered to have a higher risk of injury. **Measure:** Functional Movement Screening and range of motion tests **Time Frame:** One week **Description:** Thirty voluntary participants were randomly assigned to either RP (n=10; mean age = 20.60 ± 1.65), MP (n=10; mean age = 19.40 ± 1.35), or CG (n=10; mean age = 20.10 ± 1.15). Joint range of motion measurements were made to evaluate the joint range of motion of the athletes. Tests were conducted: shoulder hyperextension, hip flexion, hip extension, hip abduction, hip internal rotation, hip external rotation, ankle dorsiflexion, and ankle plantar flexion. Joint range of motion measurement was performed with a goniometer.Measurements were recorded in centimeters (cm). **Measure:** Range of motion tests **Time Frame:** One week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age: Adults 19 to 20 years old * Gender: Male * Volunteering players Exclusion Criteria: - Diagnosis: Diagnosis of a specific medical condition **Healthy Volunteers:** True **Maximum Age:** 20 Years **Minimum Age:** 19 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Osmaniye **Country:** Turkey **Facility:** Osmaniye Korkut Ata University **Zip:** 80000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432335 **Brief Title:** E-Socket, Diagnostic Monitoring **Official Title:** E-Socket, Diagnostic Monitoring #### Organization Study ID Info **ID:** STUDY00016676 #### Organization **Class:** OTHER **Full Name:** University of Washington ### Status Module #### Completion Date **Date:** 2030-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2025-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Washington #### Responsible Party **Investigator Affiliation:** University of Washington **Investigator Full Name:** Joan Sanders **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3). Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians. Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions. ### Conditions Module **Conditions:** - Trans-Tibial Amputation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: E-Socket Monitoring **Label:** E-Socket Monitoring **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - E-Socket Monitoring **Description:** Limb-socket motion data is collected during participant take-home use. Bimonthly telephone interviews are conducted to assess participant residual limb health status. Analysis is conducted to determine if limb motions and activity changes precede limb health changes. **Name:** E-Socket Monitoring **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health. **Measure:** Anterior-Distal Limb Motion **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Prosthesis Users: Aims 1 and 2 * Over 18 years of age * Unilateral or bilateral trans-tibial amputation at least 12 months prior * Have a limb of length 9 cm or greater * Are capable of at least 5 minutes of continuous walking * Regularly use a definitive prosthesis * Do not regularly use assistive devices (e.g., cane, walker) for ambulation * Do not have open wounds on their residual limb at the time of enrollment Aim 2 -Regularly visit their prosthetist at least twice a year, Exclusion Criteria: - Prosthesis Users: Aims 1 and 2 * Reduced skin sensation * Presence of skin breakdown * Regular use of an assistive device * Persons with trans-femoral amputation Aim 1 Only -Vacuum suspension users **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nick McCarthy **Phone:** 206-616-9148 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Washington **Name:** Joan Sanders **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432322 **Acronym:** GluEsk **Brief Title:** (GluEsk) Glutamate and Esketamine **Official Title:** Effects of Esketamine Challenge on Brain Glutamate Release (fMRS), Resting State Connectivity (BOLD-rs-fMRI), and Neuroplasticity (Visual Task) #### Organization Study ID Info **ID:** R90468/RE001 #### Organization **Class:** OTHER **Full Name:** University of Oxford ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** NIHR Oxford Health Biomedical Research Centre #### Lead Sponsor **Class:** OTHER **Name:** University of Oxford #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Esketamine is the S-enantiomer of racemic ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist. Esketamine and other antidepressant NMDA receptor antagonists are hypothesised to act by producing a rapid increase in brain glutamate release, which then stimulates α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptors. This activity in turn is thought to restore synaptic functioning, neuroplasticity, and connectivity in brain regions involved in mood regulation, which would be ultimately responsible for the antidepressant effect of esketamine However, the effect of esketamine on glutamate release in humans has not previously been studied. In this study we therefore aim to ascertain the effect of esketamine on brain glutamate release, resting state connectivity, and neuroplasticity as measured via fMRS, BOLD-rs-fMRI, and a behavioural computerised visual task respectively. **Detailed Description:** There is growing interest in the use of antagonists at the glutamate N-methyl-D-aspartate (NMDA) receptor in patients with treatment-resistant depression (TRD). Work in animal studies suggests that NMDA receptor antagonists act initially by increasing brain glutamate release, but whether such an action occurs in humans is not established. Esketamine is the S-enantiomer of racemic ketamine: a non-selective, non-competitive, antagonist of the ionotropic glutamate NMDA receptor . It is the only NMDA receptor antagonist licensed in the UK for the treatment of patients with TRD. Esketamine is administered intranasally: it is rapidly absorbed by the nasal mucosa following nasal administration and can be measured in plasma within 7 minutes following a 28 mg dose. The time to reach maximum plasma concentration (tmax) is typically 20 to 40 minutes after the last nasal spray of a treatment session. It is hypothesised that through NMDA receptor antagonism, esketamine produces a transient increase in glutamate release leading to increases in α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor stimulation and subsequently to increases in neurotrophic signalling which may contribute to the restoration of synaptic function, neuroplasticity, and connectivity in brain regions involved with the regulation of mood. Glutamate is the primary excitatory neurotransmitter in the brain and has been implicated in several neuropsychiatric disorders. "Gold-standard" methods to assess glutamate activity in the living human brain are expensive and involve radioactive injections and invasive blood sampling. More recently, work in our Clinical Psychopharmacology laboratory has shown that 7T fMRS (a more widely available, non-invasive, safe technique) that uses a visual stimulus ("flickering checkerboard") can reliably and sensitively measure changes in brain glutamate release. No prior study however has shown whether this effect is susceptible to pharmacological challenge. We therefore propose to assess whether through its NMDA/AMPA-mediated activity, esketamine can indeed produce an increase in brain glutamate release measured via this technique. The aims of this study are to investigate the effect of esketamine on brain glutamate release and resting state connectivity, and on vision. Therefore, the primary objective of this study is to assess the effect of a single dose of esketamine 56mg intranasal vs placebo on brain glutamate release changes measured via 7T fMRS "flickering checkerboard" stimulus. Secondary objectives include the investigation of the effects of esketamine on brain resting state connectivity changes measured via 7T BOLD-rs-fMRI, and on neuroplasticity measured via a behavioural computerised visual task. Psychological questionnaires will also be measured to check for possible correlations with the outcomes measured. ### Conditions Module **Conditions:** - Depression **Keywords:** - Esketamine - Brain glutamate release - fMRS - Resting state connectivity - BOLD-rs-fMRI - Neuroplasticity - Visual task - Healthy volunteers - Magnetic Resonance Spectroscopy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Within-subject, cross-over design ##### Masking Info **Masking:** DOUBLE **Masking Description:** Self-administered by the participant wearing an eye mask, following instructions and under supervision of appropriately trained medical staff where resuscitation facilities are available, via a single-use device delivering 28 mg as two sprays (i.e., one spray per nostril). **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Nasal spray solution, 56mg (28mg per nostril), intranasal **Intervention Names:** - Drug: Esketamine nasal spray **Label:** Esketamine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Nasal spray solution, 0.9% NaCl, intranasal **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Esketamine **Description:** Nasal spray solution, 56mg (28mg per nostril), intranasal **Name:** Esketamine nasal spray **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Nasal spray solution, 0.9% NaCl, intranasal **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Brain glutamate release change measured via functional Magnetic Resonance Spectroscopy (fMRS) 7-Tesla (7T) "flickering checkerboard", comparing drug vs placebo occasions. **Measure:** Brain glutamate release **Time Frame:** Acute (40-60 minutes after nasal spray application) #### Secondary Outcomes **Description:** Brain resting state connectivity change measured via blood oxygenation level-dependent resting-state functional Magnetic Resonance Imaging (BOLD-rs-fMRI) 7T, comparing drug vs placebo occasions. **Measure:** Brain resting state connectivity **Time Frame:** Acute (40-60 minutes after nasal spray application) **Description:** Behavioural visual response measured via a computerised visual task, comparing drug vs placebo occasions. **Measure:** Visual response **Time Frame:** Post-Acute (60-90 minutes after nasal spray application) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 18 to 50 years * Body Mass Index in the range of 18-30 * Sufficiently fluent in English to understand the study instructions * Willing and able to give informed consent for participation in the research Exclusion Criteria: * Currently on any regular prescribed medications (except the contraceptive pill), unless unlikely to compromise safety or affect data quality in the opinion of the Investigator * Known hypersensitivity to the study drug (i.e., esketamine) * History of, or current significant alcohol or substance misuse disorder * Any use of recreational drugs over the last 3 months * Any lifetime use of ketamine or phencyclidine (PCP) * Currently smoking \>/=20 cigarettes/day * History of, or current significant cardiovascular disorder (e.g., hypertension, myocardial infarction) * History of, or current significant neurological disorder (e.g., epilepsy, migraine) or cerebrovascular disorder (e.g., haemorrhagic or ischemic stroke, aneurysmal vascular disease, raised intracranial pressure) * History of, or current significant respiratory, hepatic, urinary tract, or thyroid disorders * History of, or current acute porphyria * History of, or current significant psychiatric disorder (e.g., psychosis, mania, depression) * History of, or current eye disorder, not including refractive error that can be corrected with glasses or contact lenses) * Pregnant, breast feeding, women of child-bearing potential not using appropriate contraceptive measures * Any contraindication to 7T MRI (see Approved Procedure: IDREC_17 Title: Non-invasive Magnetic Resonance Investigations in Healthy Volunteers) **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Wendy Howard **Phone:** 01865 618238 **Role:** CONTACT #### Locations **Location 1:** **City:** Oxford **Country:** United Kingdom **Facility:** Department of Psychiatry, University of Oxford **State:** Oxfordshire **Zip:** OX3 7JX ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ip IB, Berrington A, Hess AT, Parker AJ, Emir UE, Bridge H. Combined fMRI-MRS acquires simultaneous glutamate and BOLD-fMRI signals in the human brain. Neuroimage. 2017 Jul 15;155:113-119. doi: 10.1016/j.neuroimage.2017.04.030. Epub 2017 Apr 19. **PMID:** 28433623 **Citation:** Jewett BE, Thapa B. Physiology, NMDA Receptor. 2022 Dec 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519495/ **PMID:** 30137779 **Citation:** Li CT, Yang KC, Lin WC. Glutamatergic Dysfunction and Glutamatergic Compounds for Major Psychiatric Disorders: Evidence From Clinical Neuroimaging Studies. Front Psychiatry. 2019 Jan 24;9:767. doi: 10.3389/fpsyt.2018.00767. eCollection 2018. **PMID:** 30733690 **Citation:** Rosenbaum SB, Gupta V, Patel P, Palacios JL. Ketamine. 2024 Jan 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470357/ **PMID:** 29262083 #### See Also Links **Label:** Related Info **URL:** https://www.psych.ox.ac.uk/getinvolved/gluesk-glutamate-and-esketamine-study ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Intervention Browse Module - Ancestors - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M271980 - Name: Esketamine - Relevance: HIGH - As Found: Days per week - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: T5 - Name: Glutamic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000629870 - Term: Esketamine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432309 **Acronym:** OPAILEC **Brief Title:** Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease **Official Title:** Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel #### Organization Study ID Info **ID:** 480/2022/Oss/AOUFe #### Organization **Class:** OTHER **Full Name:** University Hospital of Ferrara ### Status Module #### Completion Date **Date:** 2024-04-25 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2022-10-01 **Type:** ACTUAL **Status Verified Date:** 2022-07 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital of Ferrara #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Levodopa-Carbidopa intestinal gel (LCIG) is an effective therapy for complicated Parkinson's disease (PD). Few studies have explored the efficacy and safety of the potential combination of LCIG with catechol-O-methyltransferase (COMT) inhibitors, particularly Opicapone (OPC). **Detailed Description:** 22 PD patients were randomized into LCIG monotherapy (n-OPC 11 patients) and LCIG+OPC (add-OPC 11 patients), further divided according to OPC adding time (E-OPC within one month and L-OPC after one month from LCIG implant). Data on PD clinical aspects, Montreal Cognitive Assessment (MoCA), Unified Parkinson's Disease Rating Scale (UPDRS), Unified Dyskinesia Rating Scale (UDysRS), electroneurography (ENG), and pharmacological therapy (Levodopa Equivalent Dose-LEDD) were collected before LCIG implanted (T0) and in the following 12 (T1) months. ### Conditions Module **Conditions:** - Parkinson Disease - Effect of Drug ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Prospective randomised blinded End-point study ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 22 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Levodopa carbidopa intestinal gel infusion. Diurnal infusion from 7.a.m to 11 p.m. **Intervention Names:** - Drug: Duodopa **Label:** nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy **Type:** OTHER #### Arm Group 2 **Description:** Levodopa carbidopa intestinal gel infusion (Diurnal infusion from 7 a.m to 11 p.m) plus Opicapone 50 mg 1 tablet at nighttime (11 p.m) **Intervention Names:** - Drug: Opicapone 50 mg - Drug: Duodopa **Label:** add-OPC: Duodopa plus OPC therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - add-OPC: Duodopa plus OPC therapy **Description:** Evaluate the addition of the COMT-I, Opicapone, to the Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations. **Name:** Opicapone 50 mg **Other Names:** - OPC **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - add-OPC: Duodopa plus OPC therapy - nOPC: Duodopa (Levodopa/carbidopa intestinal gel) in monotherapy **Description:** Evaluate Levodopa-Carbidopa intestinal gel in Parkinson's Disease patients with motor fluctuations. **Name:** Duodopa **Other Names:** - Levodopa/carbidopa intestinal gel (LCIG) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Changes in MDS-UPDRS part IV from the initial assessment to 12 months follow-up. **Measure:** Evaluation of motor fluctuations changes **Time Frame:** 12 months **Description:** Changes in UDysRS from the initial assessment to 12 months follow-up. **Measure:** Evaluation of dyskinesia changes **Time Frame:** 12 months #### Secondary Outcomes **Description:** Changes of MDS-UPDRS I score from the initial assessment to 12 months follow-up. **Measure:** Changes in non-motor aspects of patients' daily living experiences **Time Frame:** 12 months **Description:** Changes of of MDS-UPDRS II score from the initial assessment to 12 months follow-up. **Measure:** Changes in motor aspects of patients' daily living experiences **Time Frame:** 12 months **Description:** Changes of MOCA score from the initial assessment to 12 months follow-up. **Measure:** Changes in non-motor symptoms in Parkinson's disease-cognition **Time Frame:** 12 months **Description:** Changes of sural amplitude potential through electroneurography from the initial assessment to 12 months follow-up. **Measure:** Neurophysiological outcome **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. LCIG implantation not longer than 30 months before the study enrollment, 2. Presence of nocturnal akinesia (assessed by medical history and through item 2.9 of MDS-UPDRS part II (\> 2), or/and 3. Persistence of morning or afternoon akinesia (assessed by item 4.3 in MDS UPDRS -IV( \>2 ). Exclusion Criteria: 1. Hoehn \& Yahr (H\&Y) \>4, 2. Cognitive decline (MOCA\< 17), 3. more than 30 months after LCIG positioning, 4. not compliant with treatment and follow-up visits. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ferrara **Country:** Italy **Facility:** University Hospital of Ferrara - Arcispedale Sant'Anna **State:** Emilia Romagna **Zip:** 44122 #### Overall Officials **Official 1:** **Affiliation:** Azienda Ospedaliero -Universitaria S. Anna Ferrara **Name:** Mariachiara Sensi, MD-Phd **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Nyholm D, Jost WH. Levodopa-entacapone-carbidopa intestinal gel infusion in advanced Parkinson's disease: real-world experience and practical guidance. Ther Adv Neurol Disord. 2022 Jun 26;15:17562864221108018. doi: 10.1177/17562864221108018. eCollection 2022. **PMID:** 35785401 **Citation:** Fabbri M, Ferreira JJ, Lees A, Stocchi F, Poewe W, Tolosa E, Rascol O. Opicapone for the treatment of Parkinson's disease: A review of a new licensed medicine. Mov Disord. 2018 Oct;33(10):1528-1539. doi: 10.1002/mds.27475. Epub 2018 Sep 27. **PMID:** 30264443 **Citation:** Ikenaka K, Kajiyama Y, Aguirre C, Choong CJ, Taniguchi S, Doi J, Wang N, Ajiki T, Ogawa K, Kakuda K, Kimura Y, Mochizuki H. Decreased hepatic enzymes reflect the decreased vitamin B6 levels in Parkinson's disease patients. Pharmacol Res Perspect. 2024 Feb;12(1):e1174. doi: 10.1002/prp2.1174. **PMID:** 38287715 **Citation:** Leta V, van Wamelen DJ, Sauerbier A, Jones S, Parry M, Rizos A, Chaudhuri KR. Opicapone and Levodopa-Carbidopa Intestinal Gel Infusion: The Way Forward Towards Cost Savings for Healthcare Systems? J Parkinsons Dis. 2020;10(4):1535-1539. doi: 10.3233/JPD-202022. **PMID:** 32597817 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Intervention Browse Module - Ancestors - ID: D000000978 - Term: Antiparkinson Agents - ID: D000018726 - Term: Anti-Dyskinesia Agents - ID: D000015259 - Term: Dopamine Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000065105 - Term: Aromatic Amino Acid Decarboxylase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000065098 - Term: Catechol O-Methyltransferase Inhibitors - ID: D000000276 - Term: Adjuvants, Immunologic - ID: D000007155 - Term: Immunologic Factors - ID: D000018491 - Term: Dopamine Agonists ### Intervention Browse Module - Browse Branches - Abbrev: AnDyAg - Name: Anti-Dyskinesia Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CaAg - Name: Cardiotonic Agents - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M10982 - Name: Levodopa - Relevance: HIGH - As Found: Lower limb - ID: M5489 - Name: Carbidopa - Relevance: HIGH - As Found: Attending - ID: M214057 - Name: Opicapone - Relevance: HIGH - As Found: Life Support - ID: M250674 - Name: Carbidopa, levodopa drug combination - Relevance: HIGH - As Found: Few seconds - ID: M4295 - Name: Antiparkinson Agents - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M30461 - Name: Aromatic Amino Acid Decarboxylase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20595 - Name: Dopamine Agonists - Relevance: LOW - As Found: Unknown - ID: T373 - Name: Catechol - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007980 - Term: Levodopa - ID: D000002230 - Term: Carbidopa - ID: C000549349 - Term: Opicapone - ID: C000009265 - Term: Carbidopa, levodopa drug combination ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432296 **Brief Title:** Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody **Official Title:** A Randomized, Controlled, Multi-Center Phase III Clinical Study to Evaluate the Efficacy and Safety of M701 for Intraperitoneal Injection in Patients With Malignant Ascites Caused by Advanced Epithelial Solid Tumors #### Organization Study ID Info **ID:** M70104 #### Organization **Class:** INDUSTRY **Full Name:** Wuhan YZY Biopharma Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-11-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-08-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Wuhan YZY Biopharma Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A Randomized, Controlled, Multi-Center Phase III Clinical Study to Compare the Efficacy and Safety of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody (M701) for Intraperitoneal Injection to Paracentesis alone in Patients with Malignant Ascites Caused by Advanced Epithelial Solid Tumors. **Detailed Description:** The phase III study is a controlled, open-label trial designed to assess the effectiveness and safety of M701 intra-peritoneal infusion for controlling malignant ascites in patients with Malignant Ascites Caused by Advanced Epithelial Solid Tumors who are also receiving systemic therapy. A total of 270 patients with malignant ascites caused by Malignant Ascites Caused by Advanced Epithelial Solid Tumors will be randomly assigned to two treatment arms in a 2:1 ratio. These patients must have experienced disease progression or intolerance after receiving at least two lines of systemic therapy. Both treatment arms will receive the systemic therapy as per the investigator's instructions. The test arm will receive paracentesis and intra-peritoneal infusion of M701, while the control arm will receive paracentesis alone. The primary endpoint of the study is the puncture-free survival, which evaluates the efficacy of M701 in controlling malignant ascites. Secondary endpoints include the overall survival (OS),Time to next puncture (TTNP), Patient-reported outcome (PRO) score, 6-month survival rate,1-month and 2-month puncture-free survival rate, safety profiles,and Anti-m701 antibody (ADA) and Neutralizing antibody (NAb). ### Conditions Module **Conditions:** - Malignant Ascites ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 270 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** M701 will be administered via intra-peritoneal infusion following sufficient drainage of malignant ascites. The treatment regimen consists of a leading dose of 50μg on Day 1, followed by three infusions of the full dose of 400 μg M701 on Days 4, 11, and 18. If well tolerated, patients will continue to receive M701 infusions every 2 weeks as maintenance treatment.Additionally, these patients will receive systemic therapy as determined by the investigator. **Intervention Names:** - Drug: M701 **Label:** M701 group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the control group will undergo paracentesis on Day 1 and Day 18. If necessary, they may receive additional paracentesis during this period. Additionally, these patients will receive systemic therapy as determined by the investigator. **Intervention Names:** - Procedure: paracentesis **Label:** Control group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - M701 group **Description:** Intra-peritoneal infusion of M701 in experimental group (M701 group_ **Name:** M701 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Puncture and Draiange of ascites from the peritoneal cavity in both experimental group and control group **Name:** paracentesis **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Time from the end of drainage of C1V4 ascites to the beginning of the next drainage (as the time of drainage) **Measure:** TTNP **Time Frame:** Time from the end of drainage of C1V4 ascites to the beginning of the next drainage (up to 6 months). **Description:** The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 V3.0) was used to evaluate the quality of life of the subjects. This questionnaire is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. For the first 28 questions, the score is from 1-4, the lower score represents the better quality. For the last 2 quesionts, the score is from 1-7, the higher score represents the better health and quality of life. **Measure:** The score of quality of life **Time Frame:** Time from randomization to end of treatment. (up to 6 months). **Description:** 1-month and 2-month PuFS rates **Measure:** 1-month and 2-month PuFS rates **Time Frame:** 1st and 2nd month from randomization **Description:** 6-month survival rate **Measure:** 6-month survival rate **Time Frame:** 6th month from randomization **Description:** Incidence of Treatment-Emergent Adverse Events, ≥grade 3 Treatment-Emergent Adverse Events, Serious Adverse Events and Treatment-Related Adverse Events. **Measure:** Indidence of Adverse events **Time Frame:** From the time of first dosing (Day 1) until one month after the end of treatment **Description:** The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab) in the serum during the study **Measure:** Positive rate of ADA and Nab in serum **Time Frame:** Time from screening to end of treatment (up to 6 months). **Description:** Measure the count of EpCAM postive cells in the ascites before and after M701 treatment **Measure:** The EpCAM expression in ascites **Time Frame:** From the time of first dosing (Day 1) until the end of treatment (up to 6 months). #### Primary Outcomes **Description:** Defined as the time from the end of C1V4 ascites drainage to the next drainage (based on the time of puncture) or the time of death is recorded as the PuFS. **Measure:** PuFS **Time Frame:** Time from the end of drainage of C1V4 ascites to the start of the next drainage or death (up to 6 months). #### Secondary Outcomes **Description:** Time from randomization to death from any cause **Measure:** OS **Time Frame:** Time from randomization to death from any cause (up to 6 months). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Able to understand and voluntarily sign the written informed consent form; 2. Age ≥18 years and ≤75 years; 3. Histologically or pathologically confirmed epithelial malignant solid tumors,including: advanced gastric cancer and colorectal cancer that have failed at least two lines of treatment (treatment failure is defined as progression after treatment or intolerance after treatment); or platinum-resistant (platinum-efractory) dvanced ovarian cancer; 4. Pathologically or clinically diagnosed with malignant ascites, and treatment for malignant ascites is required as judged by the investigator; B-mode ultrasound confirms that the volume of ascites is moderate or above (moderate or above ascites is defined as the maximum depth of ascites by B-mode ultrasound in supine position is ≥ 4.5 cm, or the actual amount of ascites drained is ≥ 1 L; 5. The time interval between the last anti-tumor treatment and Randomization should meet the following time intervals: 1. Intraperitoneal therapy: The time from the most recent intraperitoneal infusion therapy to randomization should be ≥ 2 weeks; 2. Systemic treatment: No washout required; 3. AEs should have recovered to Grade ≤ 1 from previous treatment (except for other adverse reactions (such as alopecia) that do not affect the safety evaluation of the investigational drug as judged by the investigator according to NCI-CTCAE V5.0); 6. ECOG PS score of 0 to 2; 7. An expected survival of ≥ 8 weeks; 8. Organ functions must meet the following criteria: 1. Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelets ≥90 ×10\^9/L, hemoglobin ≥ 85 g/L, and lymphocyte percentage ≥ 10%; 2. Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (AST and ALT ≤ 5 × ULN are allowed in case of liver metastasis); 3. Serum albumin ≥ 28 g/L; 4. Renal function: serum creatinine ≤ 1.5 × ULN. 9. Female subjects of childbearing potential should have a negative pregnancy test at screening; all female subjects of childbearing potential and male subjects should take adequate contraceptive measures throughout the treatment period and within 6 months after the end of the study. Exclusion Criteria: 1. Patients with a known history of allergy to M701 or its components; patients with a known history of allergy to macromolecular ntibody drugs or a history of specific allergic reactions (asthma, rubella, and eczematous dermatitis); 2. Have previously used M701, or have used antibody drugs targeting EpCAM and/or CD3 within 4 months before the first dose; 3. Patients with central nervous system (CNS) metastases resulting in clinical symptoms or requiring therapeutic intervention; patients with previously treated brain metastases can be enrolled if they are asymptomatic and have stable disease as indicated by imaging examination ≥ 4 weeks before the first dose and do not require corticosteroids or anticonvulsant therapy; 4. Have undergone major surgery within 4 weeks prior to randomization or plan to undergo major surgery during the study(excluding exploratory surgery); 5. New or concurrent infection within 14 days prior to randomization that has not been controlled to clinical stability; 6. Patients with severe respiratory diseases at screening, leading to respiratory failure or those judged by the investigator to be unsuitable for enrollment; 7. Patients with active autoimmune diseases (e.g., inflammatory bowel disease,idiopathic thrombocytopenic purpura, lupus rythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, and rheumatoid arthritis), but patients with the following conditions are allowed to be screened: type I diabetes;hypothyroidism that can be controlled by replacement therapy only; skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, and alopecia); 8. Patients with severe cardiovascular and cerebrovascular diseases at screening,including cardiac insufficiency (NYHA Class III-IV); acute cardiovascular and cerebrovascular events (acute myocardial infarction, acute cerebral infarction,unstable angina, cerebral hemorrhage, etc.) orundergone vascular stenting within 6 months(Coronary artery stent implantation, intracranial artery stent implantation,etc.) or pulmonary embolism within the past 6 months; or venous thrombotic diseases such as venous thrombosis in lower limb within the past month; 9. Patients with complete intestinal obstruction within 30 days prior to Randomization,or those diagnosed with subileus but judged by the investigator as unsuitable for participating in the study based on their symptoms, signs, etc., or those have severe gastrointestinal disease such as gastric/intestinal perforation; 10. Unable to drain the ascites completely due to objective reasons (including ascites septation) or complicated with chylous ascites; 11. Portal vein embolism or portal hypertension confirmed by examinations; 12. Patients with active chronic hepatitis B \[such as positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis B core antibody (HBcAb), and HBV DNA ≥2000 IU/mL or HBV DNA ≥5000cps/mL\], active hepatitis C \[such as positive hepatitis C virus (HCV) antibody and HCV RNA ≥ lower limit of detection\], positive human immunodeficiency virus (HIV) antibody, or active syphilis infection (positive syphilis-specific antibody and positive syphilis non-specific antibody); 13. Patients with concurrent pleural effusion and clinical symptoms such as chest tightness and dyspnea, who have received clinical intervention or require clinical intervention as assessed by the investigator; or those with concurrent moderate to severe symptomatic pericardial effusion; 14. Pregnant or lactating women; 15. History of definitive neurological or mental disorders that, per the investigator's judgment, may affect the cognitive function or compliance of the patient, including unstable epilepsy, dementia, and schizophrenia; 16. Other conditions that the investigator considers unsuitable for participating in this clinical study. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Shaoyi Huang, PhD **Phone:** 86-27-82668988 **Phone Ext:** 8440 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Xiong Wang, MS **Phone:** 86-27-82668988 **Phone Ext:** 8440 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jianming Xu, MD - **Phone:** 010-68182255 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Rongrui Liu, MD - **Phone:** 010-68182255 - **Role:** CONTACT **Country:** China **Facility:** The First Medical Center of Chinese PLA General Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100141 **Location 2:** **City:** Harbin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yanqiao Zhang, PhD - **Phone:** 0451-85718890 - **Role:** CONTACT **Country:** China **Facility:** Harbin Medical University Cancer Hospital **State:** Heilongjiang **Status:** RECRUITING **Zip:** 150081 #### Overall Officials **Official 1:** **Affiliation:** The First Medical Center of Chinese PLA General Hospital **Name:** Jianming Xu, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** The Second Affiliated Hospital of Harbin Medical University **Name:** Yanqiao zhang, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4509 - Name: Ascites - Relevance: HIGH - As Found: Ascites ### Condition Browse Module - Meshes - ID: D000001201 - Term: Ascites ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M20194 - Name: Antibodies, Bispecific - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432283 **Brief Title:** A Machine Learning-based Estimated Survival Model **Official Title:** Construction and Validation of a Machine Learning-based Estimated Survival Model for Elderly Patients With Advanced Malignancy #### Organization Study ID Info **ID:** 2024 Review (807) #### Organization **Class:** OTHER **Full Name:** West China Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhao Siyao #### Responsible Party **Investigator Affiliation:** West China Hospital **Investigator Full Name:** Zhao Siyao **Investigator Title:** Sponser-Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Malignant tumors are the leading cause of death in elderly patients, and palliative care can improve the quality of life for elderly advanced cancer patients. One of the main reasons why these patients are not included in palliative care is the lack of accurate estimation of their survival period by patients, family members, and doctors. Both doctors and patients tend to be overly optimistic about the survival period of elderly advanced cancer patients, leading to overtreatment. Therefore, assessing the risk of death for these patients and further establishing a survival period estimation model can improve the accuracy of doctors' clinical predictions of patient survival, facilitate early referral to palliative care, and promote rationalization of medical decision-making. **Detailed Description:** 1. By searching the literature, conducting systematic reviews, and meta-analyses, we aim to uncover the prognostic factors related to death in elderly advanced cancer patients. 2. Based on evidence-based data and considering the clinical conditions of elderly advanced cancer patients in China, we will establish relevant entries for a risk assessment scale for death in elderly advanced cancer patients. By using the Delphi expert consultation evaluation method, we will finalize the assessment scale framework, laying the theoretical foundation for the establishment and validation of a death risk prediction model for elderly advanced cancer patients in China. 3. Develop a survival estimation model for elderly advanced cancer patients; through metabolomics studies and other research methods, we will investigate metabolic biomarkers related to predicting the survival period of elderly advanced cancer patients. ### Conditions Module **Conditions:** - Advanced Solid Tumor ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** advanced cancer (stage III and IV) patients aged 60 years and above who are receiving treatment at the mentioned institution. The research subjects voluntarily participate and sign informed consent forms. **Label:** advanced cancer (stage III and IV) patients aged 60 years and above. ### Outcomes Module #### Primary Outcomes **Description:** Build a survival estimation model for elderly late-stage cancer patients. **Measure:** A model **Time Frame:** 2026-12-31 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria:Inclusion criteria for late-stage malignant tumor patients: Must meet Condition 1) and also meet either Condition 2), 3), or 4): 1. Clinical diagnosis of advanced malignant tumor: TNM stage III or IV 2. "Surprise question": If this patient were to die within the next 6 months, it would not be surprising to you. 3. Karnofsky performance status (KPS) score ≤ 50 4. Palliative Performance Scale (PPS) ≤ 50% Exclusion Criteria: 1. Patients who refuse to participate in the study; 2. Patients who, for various reasons, are unable to cooperate and complete the questionnaire survey; 3. Patients who, for various reasons, are unable to cooperate and complete the follow-up. **Minimum Age:** 60 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Advanced cancer （stage III and IV） malignant tumor patients aged 60 years and above. ### Contacts Locations Module #### Locations **Location 1:** **City:** Chengdu **Country:** China **Facility:** Siyao Zhao **State:** Sichuan **Zip:** 610041 #### Overall Officials **Official 1:** **Affiliation:** West China Hospital **Name:** Siyao Zhao, postgraduate **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432270 **Brief Title:** Effect of Diabetes Mellitus on Cardiac Autonomic Function in Surgical Patients Undergoing General Anesthesia **Official Title:** A Prospective Cohort Study of the Effect of Diabetes Mellitus on Cardiac Autonomic Function in Surgical Patients Undergoing General Anesthesia #### Organization Study ID Info **ID:** 2022-KY-209-02 #### Organization **Class:** OTHER **Full Name:** Zhujiang Hospital ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhujiang Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Because autonomic neuropathy affects the constriction of thermoregulatory blood vessels, it is more difficult for diabetic patients to maintain their own body temperature in cold environments than normal people, and therefore it is more difficult for diabetic patients to maintain a relatively constant body temperature regardless of the temperature of the environment than normal people. So are diabetic patients under general anesthesia more susceptible to intraoperative hypothermia? How does heart rate variability change in diabetic patients under general anesthesia? If diabetic patients are more susceptible to intraoperative hypothermia under general anesthesia, is this related to their cardiac autonomic dysfunction? **Detailed Description:** According to the latest version of data released by the International Diabetes Federation (IDF) in 2021, it can be seen that the number of people with diabetes globally or in China is high and the percentage is increasing.In 2021, there are 537 million people with diabetes globally, and there are about 141 million in China, which is an increase of about 21.55% compared with 2019 . Perioperative hypothermia is a clinical phenomenon in which a patient's core body temperature is below 36°C for non-medical purposes during the perioperative period, with an incidence of about 7-90%, which can lead to a variety of adverse outcomes.In hot environments, sweating and vasodilation are severely compromised in diabetic patients due to autonomic neuropathy, which prevents the body from transferring heat from the inside of the body to the skin through vasodilation, increased blood flow, and sweating. Similarly, because autonomic neuropathy affects the constriction of thermoregulatory blood vessels, it is more difficult for diabetic patients to maintain their own body temperature in cold environments than normal people, and therefore it is more difficult for diabetic patients to maintain a relatively constant body temperature regardless of the temperature of the environment than normal people. On the other hand, general anesthesia and external environmental factors in the operating room increase the incidence of intraoperative hypothermia, and theoretically, diabetic patients are more prone to dramatic fluctuations in their own body temperature during surgery, making it difficult for them to adapt to changes in the external environment. Due to the complex pathophysiological mechanism of diabetes, which affects multiple systems throughout the body, there are currently more than 100 complications of diabetes, of which autonomic neuropathy has the most serious impact on diabetic patients. Cardiac autonomic neuropathy is one of the most common and serious complications of diabetic autonomic neuropathy, with a prevalence of 63% . And heart rate variability is one of the most common tests for diabetic cardiac autonomic dysfunction. So are diabetic patients under general anesthesia more susceptible to intraoperative hypothermia? How does heart rate variability change in diabetic patients under general anesthesia? If diabetic patients are more susceptible to intraoperative hypothermia under general anesthesia, is this related to their cardiac autonomic dysfunction? However, there are still no studies and little attention has been paid to it. ### Conditions Module **Conditions:** - Diabetic Autonomic Neuropathy Type 2 - Perioperative Complication - Temperature Change, Body **Keywords:** - diabetes - general anesthesia - Cardiac autonomic dysfunction - perioperative temperature ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 388 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 3 Days ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with a diagnosis of diabetes mellitus who are about to undergo general anesthesia who are expected to undergo laparoscopic surgery **Label:** diabetic group #### Arm Group 2 **Description:** Nondiabetic patients anticipating laparoscopic surgery who are about to undergo general anesthesia **Label:** Non-diabetic group ### Outcomes Module #### Other Outcomes **Description:** Age of the participants(years) **Measure:** Age **Time Frame:** the preoperative visit period **Description:** Height of the participants(meters) **Measure:** Height **Time Frame:** the preoperative visit period **Description:** BMI of the participants(kg/m2) **Measure:** BMI **Time Frame:** the preoperative visit period #### Primary Outcomes **Description:** The study was conducted by using a perioperative core body temperature monitoring system to continuously monitor and record core body temperature data for 12 hours preoperatively - intraoperatively - 12 hours postoperatively, and then calculating the mean core body temperature per minute at 12 hours preoperatively, intraoperatively, and 12 hours postoperatively, respectively, to compare whether diabetic patients had lower mean core body temperature per minute intraoperatively than non-diabetic patients, and whether diabetic patients had a decrease in intraoperative body temperature compared to 12 hours preoperatively and 12 hours postoperatively. Mean intraoperative core body temperature per minute (°C/min) = Mean intraoperative core body temperature/operating time. **Measure:** Changes in perioperative core body temperature in diabetic patients **Time Frame:** 12 hours before surgery,during operation,12 hours after surgery #### Secondary Outcomes **Description:** observing the time period during which diabetic and non-diabetic patients began to drop below the mean temperature at 12 hours preoperatively and comparing how early or late the temperature began to drop in both groups **Measure:** time to onset of temperature drop **Time Frame:** Baseline and 12 hours before surgery,0-30 minutes after induction ,30-60 minutes after induction,60-90 minutes after induction,90-120 minutes after induction,120-150 minutes after induction,150-180 minutes after induction,12 hours after surgery **Description:** Observing the period of time during which diabetic and non-diabetic patients experienced a drop in temperature to nadir, and comparing how fast or slow the temperature dropped to the lowest point **Measure:** time to temperature drop to nadir **Time Frame:** Baseline and 12 hours before surgery,0-30 minutes after induction ,30-60 minutes after induction,60-90 minutes after induction,90-120 minutes after induction,120-150 minutes after induction,150-180 minutes after induction,12 hours after surgery **Description:** Comparing whether the average core body temperature of diabetic patients was lower than that of non-diabetic patients at each time period after induction. **Measure:** The magnitude of body temperature decline **Time Frame:** Baseline and 12 hours before surgery,0-30 minutes after induction ,30-60 minutes after induction,60-90 minutes after induction,90-120 minutes after induction,120-150 minutes after induction,150-180 minutes after induction,12 hours after surgery **Description:** using 24-hour Holter ECG to collect HRV data from 12 hours before surgery to induction (first administration of medication), and from the time the patients left the recovery room to 12 hours after surgery, and observing the changes in HRV data of the patients of the two groups in the two time periods **Measure:** Changes in heart rate variability (HRV) **Time Frame:** 12 hours before surgery,12 hours after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years old ≤ age ≤ 80 years old, gender is not limited; * BMI index of 18-35 kg/m2 (including 18 kg/m2 and 35 kg/m2 ); * Diagnosed with diabetes mellitus; * ASA Ⅰ - Ⅱ; * Elective laparoscopic abdominal surgery under general anesthesia; * Operating time \>2 hours and \<6 hours; * Voluntary participation and signing of an informed consent form; * Ability to be followed up in a timely manner. Exclusion Criteria: * Abnormally elevated preoperative inflammatory indicators; * Core body temperature ≥37.5 degrees Celsius; * Patients with previous clear central nervous system disease, history of psychiatric disorders, or epilepsy; * Patients with verbal communication or hearing or visual impairment, who were unable to communicate well and had poor compliance; * Intraoperative use of vasodilator (uradil, sodium nitroprusside, nitroglycerin); * Any high-risk subjects with complete atrioventricular block or complete atrioventricular conduction tissue without implanted pacemakers, multiple premature ventricular beats, single premature ventricular beats (heart rate \<45 beats/min), heart failure in NYHA (New York Heart Association) class III or higher; * Subjects with any other clinically significant 12-lead electrocardiogram (ECG) or echocardiogram abnormality at the time of screening, ejection fraction (EF) \<40%, or any other significant abnormality in the opinion of the investigator; * Subjects deemed by the investigator to be unfit for this clinical trial for any other reason (anesthesia assessment unfit for surgery or preanesthetic hypertension). Withdrawal Criteria: * Serious adverse events, abnormal laboratory tests, or other conditions that indicate no further benefit or increased risk to the subject's safety from continued participation in the study; * Incomplete recording of critical data (temperature or heart rate variability); * Unstable condition requiring further admission to the intensive care unit; * Intraoperative use of dexmedetomidine; 5. Perioperative nerve block. **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This study is expected to collect patients who are hospitalized in Zhujiang Hospital of Southern Medical University and are proposed to undergo surgery ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xinying Wang, Master **Phone:** 86-13539410563 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Southern Medical University, China **Name:** Zhujiang Hospital of Southern Medical University **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000048909 - Term: Diabetes Complications ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M4643 - Name: Autonomic Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M27979 - Name: Primary Dysautonomias - Relevance: LOW - As Found: Unknown - ID: M7124 - Name: Diabetic Neuropathies - Relevance: HIGH - As Found: Diabetic Autonomic Neuropathy - ID: M5111 - Name: Body Temperature Changes - Relevance: HIGH - As Found: Temperature Change, Body - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003929 - Term: Diabetic Neuropathies - ID: D000003920 - Term: Diabetes Mellitus - ID: D000001832 - Term: Body Temperature Changes ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432257 **Brief Title:** The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery **Official Title:** The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery #### Organization Study ID Info **ID:** NO.SWYX2024-280 #### Organization **Class:** OTHER_GOV **Full Name:** Shandong Provincial Hospital ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2020-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shandong University #### Lead Sponsor **Class:** OTHER_GOV **Name:** Shandong Provincial Hospital #### Responsible Party **Investigator Affiliation:** Shandong Provincial Hospital **Investigator Full Name:** Guojun Wu **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study collected data on open thyroidectomy patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery. This study investigated whether the application of head mounted magnifying glasses had an impact on preoperative and postoperative changes in PTH levels through inter group and self pre - and post control, in order to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery and provide reasonable suggestions for the selection of subsequent surgical treatment methods. **Detailed Description:** In thyroid surgery, changes in postoperative parathyroid hormone (PTH) levels have a significant impact on the patient\&#39;s recovery and long-term health status. Parathyroid hormone is responsible for regulating blood calcium levels, and its dysfunction can cause serious electrolyte imbalance and metabolic problems. In the process of thyroid surgery, especially in total thyroidectomy, protecting the function of the parathyroid gland is an important operation. The diameter of the parathyroid gland is small and similar to the morphology of lymph nodes, making it susceptible to damage during surgery. Although traditional magnification tools such as surgical microscopes have certain effects, their operation is complex and their adaptability to surgical scenes is limited. In recent years, as an emerging magnifying tool, head mounted magnifying glasses have been increasingly used in thyroid surgery due to their portability, ease of operation, and providing a larger field of view. Wearing a head mounted magnifying glass can not only improve the clarity of vision during surgery, increase the recognition rate of parathyroid glands and nerves, but also reduce the risk of parathyroid injury by improving surgical accuracy, thereby more effectively maintaining the stability of postoperative PTH levels. In addition, the use of head mounted magnifying glasses can reduce surgical time, intraoperative uncertainty, and the risk of postoperative complications. This study systematically evaluates the changes in PTH levels before and after surgery to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery, and further explores the effectiveness of parathyroid gland protection strategies, optimizing surgical techniques, and improving patient surgical safety and postoperative quality of life. In addition, the results of this study also have guiding significance for the innovation and improvement of surgical instruments, which may promote the development of related technologies and equipment, and thus promote their application in a wider range of surgical fields. ### Conditions Module **Conditions:** - Thyroid Cancer **Keywords:** - thyroid cancer - PTH - Head mounted magnifying glass ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery. **Intervention Names:** - Device: head mounted magnifying glass assistance **Label:** Using the head mounted magnifying glass ### Interventions #### Intervention 1 **Arm Group Labels:** - Using the head mounted magnifying glass **Description:** When performing thyroid surgery for patients in the experimental group, the surgeon uses a head mounted magnifying glass for assistance **Name:** head mounted magnifying glass assistance **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** To verify the practical effectiveness of wearing a magnifying glass in thyroid surgery by examining changes in PTH levels before and after surgery. **Measure:** PTH level **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All cases were the first to undergo open thyroidectomy surgery. * All clinical data and research materials of the cases are complete. * All cases underwent thyroid function examination before and after surgery. * All cases in the experimental group were treated with a head mounted magnifying glass during surgery. Exclusion Criteria: * Except for cases of recurrence. * Cases with incomplete clinical data and research materials are excluded. * Cases that have not undergone thyroid function tests before and after surgery are excluded. * Excluding cases of secondary surgery. * Excluding cases in the experimental group who did not use a head mounted magnifying glass during surgery. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** This study collected patients who underwent open thyroidectomy surgery at the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023. All patients included in the study had complete clinical and research data, with approximately 2000 participants. ### Contacts Locations Module #### Locations **Location 1:** **City:** Jinan **Country:** China **Facility:** Shandong provincial hospital **State:** Shandong **Zip:** 250102 ### IPD Sharing Statement Module **Description:** The data are not publicly available due to privacy and ethical restrictions. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M16723 - Name: Thyroid Neoplasms - Relevance: HIGH - As Found: Thyroid Cancer - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000013959 - Term: Thyroid Diseases ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432244 **Brief Title:** The Effect of the Number of Central Lymph Nodes on Changes in Parathyroid Function **Official Title:** The Effect of the Number of Central Lymph Nodes on Changes in Parathyroid Function #### Organization Study ID Info **ID:** NO.SWYX2024-279 #### Organization **Class:** OTHER_GOV **Full Name:** Shandong Provincial Hospital ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2020-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shandong University #### Lead Sponsor **Class:** OTHER_GOV **Name:** Shandong Provincial Hospital #### Responsible Party **Investigator Affiliation:** Shandong Provincial Hospital **Investigator Full Name:** Guojun Wu **Investigator Title:** principle investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study collected data from patients who underwent thyroidectomy in the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. The main calculation indicator was the changes in PTH before and after surgery. This study grouped patients based on the number of central lymph nodes under postoperative paraffin pathology, and statistically analyzed the changes and differences in PTH before and after surgery in different groups to verify the relationship between the number of central lymph nodes in the thyroid gland and parathyroid function, and to provide reference for surgical selection in thyroid cancer patients with multiple cervical lymph node metastases. **Detailed Description:** The central lymph nodes of the thyroid gland refer to the lymph nodes located around the thyroid and trachea. The central lymph nodes are the primary site of thyroid cancer metastasis, and therefore play an important role in thyroid surgery. In thyroid surgery, preventive central lymph node dissection is a routine procedure, but during this process, the parathyroid gland may be impaired due to surgical injury or insufficient blood supply. Hypothyroidism, also known as parathyroidism, is a common complication of thyroid surgery. When the parathyroid gland is accidentally injured or its blood supply is disrupted, it can lead to insufficient production of parathyroid hormone. Parathyroid hormone is a key hormone that regulates blood calcium levels. Insufficient levels can lead to hypocalcemia, manifested as hand and foot spasms, muscle spasms, and even arrhythmia. From a surgical perspective, the number of lymph nodes in the central region of the thyroid gland may affect the preservation and functional protection of the parathyroid gland. A large number of lymph nodes indicates that they may have a wider range of disease invasion, requiring more thorough lymph node dissection, thereby increasing the risk of damaging the parathyroid gland or its blood supply. ### Conditions Module **Conditions:** - Thyroid Cancer **Keywords:** - thyroid cancer - central lymph nodes - PTH ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** By exploring the relationship between the number of lymph nodes in the central region of the thyroid gland and parathyroid function, evaluate the effectiveness of different surgical procedures and intraoperative protective measures on parathyroid function protection. **Label:** Number of central lymph node dissection ### Outcomes Module #### Primary Outcomes **Description:** This study grouped the central lymph nodes based on postoperative paraffin pathology, and statistically analyzed the changes and differences in PTH before and after surgery in different groups to verify the relationship between the number of central lymph nodes in the thyroid gland and parathyroid function. **Measure:** PTH level **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All cases were the first to undergo thyroidectomy surgery. * All clinical data and research materials of the cases are complete. * All cases underwent thyroid function examination before and after surgery. * All cases underwent preoperative thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital. Exclusion Criteria: * Except for cases of recurrence. * Cases with incomplete clinical data and research materials are excluded. * Cases that have not undergone thyroid function tests before and after surgery are excluded. * Excluding cases of secondary surgery. * Cases that have not undergone thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital before surgery are excluded. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** This study collected data from patients who underwent thyroidectomy surgery at the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023. All patients included in the study had complete clinical data and research materials, with approximately 2000 participants. ### Contacts Locations Module #### Locations **Location 1:** **City:** Jinan **Country:** China **Facility:** Shandong provincial hospital **State:** Shandong **Zip:** 250102 ### IPD Sharing Statement Module **Description:** The IPD are not publicly available due to privacy and ethical restrictions. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013959 - Term: Thyroid Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: LOW - As Found: Unknown - ID: M16723 - Name: Thyroid Neoplasms - Relevance: HIGH - As Found: Thyroid Cancer - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013964 - Term: Thyroid Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13194 - Name: Parathyroid Hormone - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432231 **Brief Title:** Effects of Low Glycemic Index Diet in Children With Drug-resistant Epilepsy **Official Title:** The Effects of Low Glycemic Index Diet on Epileptic Seizure Frequency, Oxidative Stress, Mental Health, and Health-related Quality of Life in Children With Drug-resistant Epilepsy #### Organization Study ID Info **ID:** 2022-GAP-SABF-0052 #### Organization **Class:** OTHER **Full Name:** Izmir Katip Celebi University ### Status Module #### Completion Date **Date:** 2024-02-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-02-20 **Type:** ACTUAL #### Start Date **Date:** 2022-08-28 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Izmir Katip Celebi University #### Responsible Party **Investigator Affiliation:** Izmir Katip Celebi University **Investigator Full Name:** Gamze Yurtdaş Depboylu **Investigator Title:** Associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial was to evaluate the effectiveness of a low glycemic index diet (LGID) on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy. Based upon the aims, the following hypotheses were tested: 1. LGID reduces seizure frequency in children with drug-resistant epilepsy. 2. LGID improves oxidative parameters in children with drug-resistant epilepsy 3. LGID improves quality of life and mental health in children with drug-resistant epilepsy Participants were prescribed the LGID for 3 months.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements were collected. Diet compliance was evaluated by food consumption records during monthly follow-up visits (at 1 , 2, and 3 months). **Detailed Description:** The aim of this study was to evaluate the efficacy of a low glycemic index diet on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy.This study was a prospective, non-randomized, single centre intervention conducted in children with drug-resistant epilepsy. Low glycemic index diet was started on an out-patient basis. Children and their parents were educated about the diet and the effect of the diet on seizures. Children who were willing to follow the diet were included in the study. The research dietitian conducted interviews with patients and their parents at the beginning of the study to explain the principles of the diet.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements including oxidative stress parameters were collected. A 3-day dietary intake chart kept by the parents was reviewed at each monthly visit to check and reinforce compliance. Parents were asked to record the seizure frequency and severity in a seizure diary. ### Conditions Module **Conditions:** - Ketogenic Diet - Drug Resistant Epilepsy - Oxidative Stress - Quality of Life - Psychological Health ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 34 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Children with drug-resistant epilepsy were treated with a low glycemic index diet for 3 months. **Intervention Names:** - Other: Low glycemic index diet treatment **Label:** Low glycemic index diet treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Low glycemic index diet treatment **Description:** This study was a non-randomized, single centre, pre/post-intervention study. A low glycemic index diet was prescribed by a dietician for 3 months. LGID treatment consisted of 10% (40-60 g) low glycaemic index (glycaemic index \<50) carbohydrate, 20-30% protein and 60-70% lipid **Name:** Low glycemic index diet treatment **Other Names:** - LGID **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Seizure diary was kept by parents to records seizure frequency and severity **Measure:** Changes in seizure frequency **Time Frame:** Baseline and Month 3 **Description:** Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS)) **Measure:** Concentration of antioxidant and oxidant status **Time Frame:** Baseline and Month 3 **Description:** Measurement of Paraoxonase Enzyme Activity (PON-1) **Measure:** Concentration of Paraoxonase Enzyme Activity **Time Frame:** Baseline and Month 3 **Description:** Measurement of Malondialdehyde (MDA) **Measure:** Concentration of Malondialdehyde (MDA) **Time Frame:** Baseline and Month 3 **Description:** "Pediatric Inventory of Quality of Life" was applied to assess health-related quality of life. A higher score corresponds to a higher health-related quality of life. The score ranges from 0 to 100 **Measure:** Changes in quality of life **Time Frame:** Baseline and Month 3 **Description:** Psychosocial problems were assessed by the "Strengths and Difficulties Questionnaire".The questionnaire includes 25 questions, some of which question positive and some of which question negative behavioral characteristics. These questions are grouped under 5 sub-headings. These are behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems and social behaviors. Each heading is evaluated in itself with scores that range from 0 to 10 and the sum of the first four headings gives the "total difficulty score". While high scores in social behavior reflect the individual's strengths in the social domain, high scores in the other four domains (behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems) reflect that the problem areas are severe. **Measure:** Changes in psychosocial problems **Time Frame:** Baseline and Month 3 **Description:** Depression status was assessed by the "Children's Depression Scale".Scores that can be obtained from the scale can vary between 0-54. The cut-off point of the depression scale for children is 19, and high scores indicate a high risk of depression. **Measure:** Changes in depression level **Time Frame:** Baseline and Month 3 #### Secondary Outcomes **Description:** Measurement of glucose **Measure:** Concentration of glucose **Time Frame:** Baseline and Month 3 **Description:** Measurement of insulin **Measure:** Concentration of insulin **Time Frame:** Baseline and Month 3 **Description:** Measurement of Alanine transaminase (ALT) and Aspartate transaminase (AST) **Measure:** Concentration of liver function tests **Time Frame:** Baseline and Month 3 **Description:** Measurement of total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), serum triglyceride (mg/dl) **Measure:** Changes in lipid profile **Time Frame:** Baseline and Month 3 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being between the ages of 4-18, * being diagnosed with drug-resistant epilepsy, * having more than one seizure per week, * not having followed a ketogenic diet before. * willing to come for regular follow up Exclusion Criteria: * children with known or suspected congenital metabolic, chronic, and systemic diseases in which ketogenic diet is contraindicated. * non-compliance with the diet recommended by the patient and/or parents * enteral tube or parenteral feeding **Maximum Age:** 18 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Çi̇ğli̇ **Country:** Turkey **Facility:** Gamze Yurtdaş Depboylu **State:** İ̇zmi̇r ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M7983 - Name: Epilepsy - Relevance: HIGH - As Found: Epilepsy - ID: M369 - Name: Drug Resistant Epilepsy - Relevance: HIGH - As Found: Drug Resistant Epilepsy - ID: M15452 - Name: Seizures - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000004827 - Term: Epilepsy - ID: D000069279 - Term: Drug Resistant Epilepsy ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432218 **Brief Title:** Patient Education in the Clinical Management of Pessary **Official Title:** A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary #### Organization Study ID Info **ID:** K5558 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2026-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Peking University People's Hospital **Class:** OTHER **Name:** Shandong University **Class:** OTHER **Name:** Tongji Hospital **Class:** OTHER **Name:** Third Military Medical University **Class:** OTHER **Name:** Changsha Hospital for Maternal and Child Health Care **Class:** UNKNOWN **Name:** Hangzhou Women's Hospital **Class:** OTHER **Name:** Shenzhen People's Hospital **Class:** UNKNOWN **Name:** Foshan Women and Children Hospital #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared. ### Conditions Module **Conditions:** - Pelvic Organ Prolapse ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 280 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Watch video as well as receive conventional guidance. **Intervention Names:** - Other: video education - Other: conventional education **Label:** the conventional education plus video education group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Receive conventional guidance. **Intervention Names:** - Other: conventional education **Label:** the conventional education group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - the conventional education plus video education group **Description:** A re-watchable video provided before pessary fitting which mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. **Name:** video education **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - the conventional education group - the conventional education plus video education group **Description:** Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting. **Name:** conventional education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Continued usage of the pessary and have very much or much improvement in the patient impression of improvement (PGI-I) questionnaire at 1 year. **Measure:** Continued usage with satisfaction **Time Frame:** 12 months after pessary fitting. #### Secondary Outcomes **Description:** Self-rated score from 0 to 10 points (higher scores mean a better outcome). **Measure:** Knowledge of pessary **Time Frame:** Baseline and at pessary fitting. **Description:** Self-rated score from 0 to 10 points (higher scores mean a better outcome). **Measure:** Willingness to treatment **Time Frame:** Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting. **Description:** 7-item generalized anxiety disorder questionnaire (GAD-7) (the range of scores is 0-21, and higher scores mean a worse outcome), and self-rated score of sleep quality from 0 to 10 points (higher scores mean a better outcome). **Measure:** Anxiety about pessary use **Time Frame:** Baseline and at pessary fitting. **Description:** Self-rated score from 0 to 10 points (higher scores mean a better outcome). **Measure:** Ability to self-manage **Time Frame:** 3 and 12 months after successful pessary fitting. **Description:** Self report and physical examination. **Measure:** Treatment-related symptoms and complications **Time Frame:** 3 and 12 months after successful pessary fitting. **Description:** Pelvic floor impact questionnaire-7 (PFIQ-7) (the range of scores is 0-300, and higher scores mean a worse outcome) **Measure:** Improvement in symptoms **Time Frame:** 3 and 12 months after successful pessary fitting. **Description:** Pelvic floor distress inventory-20 (PFDI-20) (the range of scores is 0-300, and higher scores mean a worse outcome) **Measure:** Improvement in quality of life **Time Frame:** 3 and 12 months after successful pessary fitting. **Description:** The pelvic organ prolapse/urinary incontinence sexual questionnaire short form (PISQ-12) (the range of scores is 0-48, and higher scores mean a worse outcome) **Measure:** Improvement in sexual activity **Time Frame:** 3 and 12 months after successful pessary fitting. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Symptomatic pelvic organ prolapse of stage II\~IV * Ability to participate in clinical trial and follow-up * The patient and family understand the study, are willing to participate in the 1-year study, and provide written informed consent Exclusion Criteria: * Acute phase of infection of the internal and/or external genital tracts * Genital fistula * Suspected or untreated lower genital tract tumors * Abnormally elevated intra-abdominal pressure (e.g., ascites, tumors) * Life expectancy less than 1 year * Cognitive or language communication disorders * Unable to watch video (e.g., blindness) **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ying Zhou, MD **Phone:** +8613681253992 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ying Zhou, MD - **Phone:** +8613681253992 - **Role:** CONTACT ***Contact 2:*** - **Name:** Lan Zhu, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Peking Union Medical College Hospital **State:** Beijing **Zip:** 100730 #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital **Name:** Lan Zhu, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14261 - Name: Prolapse - Relevance: HIGH - As Found: Prolapse - ID: M28618 - Name: Pelvic Organ Prolapse - Relevance: HIGH - As Found: Pelvic Organ Prolapse - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011391 - Term: Prolapse - ID: D000056887 - Term: Pelvic Organ Prolapse ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432205 **Brief Title:** The Effect of MDT Plus SDM on Survival Benefit of Advanced Gastric Cancer **Official Title:** The Effect of Multi-Disciplinary Team Plus Shared-Decision Making on Survival Benefit of Advanced Gastric Cancer - a Single Center, Non-randomized, Prospective, Controlled Study #### Organization Study ID Info **ID:** 2023YJZ66 #### Organization **Class:** OTHER **Full Name:** Peking University ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-09 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this observational study is to learn about the long-term effect of surgery in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation. The main question it aims to answer is: Does surgery extend survival time in metastatic gastric cancer patients who are accessed as having opportunity for surgery under Multi-disciplinary Team (MDT) evaluation? **Detailed Description:** Select metastatic gastric cancer patients that have the opportunity to undergo any forms of surgery through MDT. Then further evaluate these patients' risks and benefits. Let patients make their finally decision through shared-decision making (SDM). According to the actual decision, the patients are divided into surgery group and non-surgery group. ### Conditions Module **Conditions:** - Gastric Cancer **Keywords:** - multi-disciplinary Team - shared-decision making - surgery ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 121 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose to undergo surgery after MDT plus SDM. **Intervention Names:** - Procedure: surgery **Label:** surgery group #### Arm Group 2 **Description:** metastatic gastric cancer patients who are assessed as having the opportunity for surgery finally choose not to undergo surgery after MDT plus SDM. **Label:** non-surgery group ### Interventions #### Intervention 1 **Arm Group Labels:** - surgery group **Description:** any forms of surgery, such as all tumor resection, partial tumor resection and palliative tumor resection surgery **Name:** surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** overall survival **Time Frame:** From diagnosis of metastatic gastric cancer to any cause of death，assessed up to 5 years #### Secondary Outcomes **Measure:** progression free survival **Time Frame:** From diagnosis of metastatic gastric cancer to tumor progression or any cause of death, assessed up to 2 years **Description:** any grade of adverse event **Measure:** safety of surgery **Time Frame:** after surgery, assessed up to 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years old; * Participate in the formal MDT discussion and evaluate feasible surgical treatment; * Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histology; * Immunotherapy must be received during the treatment; * At least 1 distant metastatic organs, and the number of metastases is ≥1; * The subject line blood routine (within 7 days) and biochemical indicators (within 14 days) meet the following standards: hemoglobin≥90g/L； absolute count of neutral granulocytes (ANC) ≥1.5×10\^9/L； platelets≥100×10\^9/L； Alt, AST≤ 2.5 times the normal upper limit，≤5 times the normal upper limit value (with liver metastasis)； ALP ≤ 2.5 times the normal upper limit，≤5 times the normal upper limit (with liver or bone metastasis)； total bilirubin\<1.5 times the normal upper limit value of serum； serum creatinine\<1.5 times normal upper limit； albumin≥30g/L； * ECOG 0 ～ 1 point; * The expected life span is ≥3 months; * Cardiopulmonary function is basically normal; * Women and spouses of childbearing age are willing to adopt effective contraceptive methods. Exclusion Criteria: * Those who do not meet the above selected standards or have chemotherapy contraindications; * Combined with other primary malignant tumors; * Pregnancy, lactating women or women of childbearing age and spouses refuse to adopt effective contraceptive methods; * History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation); * History of long -term treatment of steroids (Note: Short -term users discontinue drugs\> 2 weeks can be selected); * History of peripheral nervous system disorders or obvious mental disorders and central nervous system disorders; * Accompanied by severe infection; * Accompanied by swallowing difficulties, complete or incomplete digestive tract obstruction, gastrointestinal bleeding, perforation, etc.; * Severe liver disease (such as liver cirrhosis, etc.), kidney disease, respiratory disease, or chronic system diseases such as diabetes, hypertension, high blood pressure; * Coronary heart disease with obvious clinical symptoms, such as: congestive heart failure, obvious symptoms, cardiac disorders, hypertension, or myocardial infarction seizures, or inadequate heart function within 6 months; * Persons without legal capacity, medical or ethical reasons affecting the continuation of research. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patient in Beijing Cancer Hospital ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiaotian Zhang, professor **Phone:** 010-88196561 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** Xiaotian Zhang, Professor - **Role:** CONTACT **Country:** China **Facility:** Beijing Cancer Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100142 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: HIGH - As Found: Gastric Cancer ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432192 **Acronym:** ApoDiag **Brief Title:** A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis **Official Title:** ApoDiag: A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis #### Organization Study ID Info **ID:** 2023-A02120-45 #### Organization **Class:** INDUSTRY **Full Name:** Firalis SA ### Status Module #### Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Firalis SA #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro-diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests detect several gene mutations related to the above-mentioned pathologies. The development of IVD tools requires the evaluation of analytical parameters including biomarker stability. The present specific study therefore aims to collect whole blood samples in PAXgene DNA tubes to complete the analytical validation of IVD tools and the evaluation of the stability of the DNA in PAXgene DNA tubes and the reagents in the IVD tools. ### Conditions Module **Conditions:** - Genetic Health Risks **Keywords:** - Polygenic risk, APOE, Apolipoprotein, Neurodegenerative disorders, dementia, Alzheimer disease, genetic risks ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The cohort will be genotyped to determine the phenotype of the APOE allele **Intervention Names:** - Diagnostic Test: APO-Easy **Label:** APOE E ### Interventions #### Intervention 1 **Arm Group Labels:** - APOE E **Description:** Testing for the APOE genotype using the APO-Easy Genotyping test **Name:** APO-Easy **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Establish the feasibility of detecting several gene mutations associated with the risk of Alzheimer's disease/ Cardiovascular disorder and validation of analytical parameters **Measure:** APOE Genotype **Time Frame:** Baseline #### Secondary Outcomes **Description:** Establish the stability of PAXgene DNA samples at different timepoints after storage at -20° and -80°C. **Measure:** Specimen stability **Time Frame:** Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Donors who sign the informed consent forms for sample collection and for genotyping. * Adults, both genders, aged 18-85 years. * Not under any administrative or legal supervision Exclusion Criteria: * Anyone who did not sign the Informed Consent form. * Subjects aged below 18 years and older than 85 years are excluded. * Pregnant, parturient and nursing women are excluded **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Healthy donors ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rodwell Mkhwananzi, MD **Phone:** 03 89 91 13 20 **Role:** CONTACT #### Locations **Location 1:** **City:** Strasbourg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Catherine HUMBRECHT, MD - **Phone:** 03 88 21 25 25 - **Role:** CONTACT **Country:** France **Facility:** EFS GEST **Status:** RECRUITING **Zip:** 67000 #### Overall Officials **Official 1:** **Affiliation:** Firalis SA **Name:** Huseyin Firat, MD PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M3885 - Name: Alzheimer Disease - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432179 **Acronym:** volunteer **Brief Title:** Hospice Volunteer Community，Dying Patient Prepare Spirtal Care **Official Title:** Pathways to Hospice Volunteering: a Grounded Theory Study #### Organization Study ID Info **ID:** 202303083RINC #### Organization **Class:** OTHER **Full Name:** National Taiwan University Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-06-15 **Type:** ACTUAL #### Start Date **Date:** 2023-04-29 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2023-05-01 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Taiwan University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Due to the aging population, the cases of elderly disability and death caused by chronic diseases and cancer are also increasing; thus increasing the demand and trend of community palliative care. Anning volunteers are members of the Anning team and play an integral role in the care of the "whole community". Partners who can provide psychosocial support in fear, grief, informal care, and "individualized care" can focus on patient and family needs and give their time and presence. And make up for the shortage of medical manpower. Assist nurses to take care of patients together, which is an important support for nursing care. In the community, An Ning volunteers are an important help to closely care for patients and support family members to take care of them at home and fulfill their wish of dying at home. In view of the community's peaceful home care, the trend and importance of hospice at home, it is necessary to cooperate with the "volunteers" of the tranquility team. Inquiry Only a few papers mentioned Anning volunteers' service history and research on the meaning of life, but there was a lack of in-depth and systematic discussions on Anning volunteers, including their motivation, training, process, care effectiveness, impact on training volunteer organization management, and volunteer retention. Therefore, the motivation of the research was aroused, and it was hoped to use grounded theory to explore the motivation and process of becoming an Anning volunteer, and to identify related concepts, and finally establish a theoretical framework to describe the relevant decision-making mentality. Also serves as a reference for volunteer organization management training and retention of palliative care volunteers. **Detailed Description:** This study adopts the grounded theory method in qualitative research.The researchers recruited potential study participants at a community-based spiritual care training facility It is estimated that about 20-30 research participants are needed to achieve data saturation. Inclusion criteria: (1) Adults aged 18 or above (2) Community peace volunteers who have served for more than one year (including one year), currently serving volunteers or stop serving volunteers (3) able to Communicate in Mandarin or Taiwanese. Those who could not understand or conduct the interview due to any physical or psychological or cognitive factors were excluded.used Semi-structured interview guide. The data coding of grounded theory is divided into three layers: open coding, axial coding and selective coding; through these three layers of coding, the data are decomposed, compared, conceptualized and integrated, and finally form a theory we have 23 volunteers were recruited and interviewed. Finally, 21 volunteers were interviewed. Two of them were volunteers who resigned due to poor health and working hours that could not accommodate volunteer services. The average interview time was 44 minutes, with 20 women and 1 man. It took a total of 6 weeks to complete the interviews 24 weeks analysis data ### Conditions Module **Conditions:** - Hospital Acquired Condition **Keywords:** - hospice Volunteer ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pathways to hospice volunteering: a grounded theory study **Label:** hospice volunteer ### Outcomes Module #### Primary Outcomes **Description:** Using qualitative research to interview volunteers' motivations, journeys and training processes as volunteers **Measure:** Pathways to hospice volunteering: a grounded theory study bason interview interview The 60-minute in week 24 **Time Frame:** base on week 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adults aged 18 or above (2) Community hospice volunteers, who have served for more than one year (including one year), are currently serving volunteers or have stopped serving volunteers (3) Can speak Mandarin or Taiwanese communicate. Exclusion Criteria: * Those who could not understand or conduct the interview due to any physical or psychological or cognitive factors were excluded. * no Dmentia stroke **Gender Based:** True **Gender Description:** men and women **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Community hospice volunteers ### Contacts Locations Module #### Locations **Location 1:** **City:** Taipei county **Country:** Taiwan **Facility:** Nation Taiwan university hospictal **Zip:** 100 #### Overall Officials **Official 1:** **Affiliation:** professer **Name:** Chia-Chun Tang, PHD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Possibility to give back to training institution results **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10099 - Name: Iatrogenic Disease - Relevance: HIGH - As Found: Hospital Acquired Condition - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007049 - Term: Iatrogenic Disease ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432166 **Acronym:** 2-HOBA **Brief Title:** 2-Hydroxybenzylamine (2-HOBA) Study in Early Alzheimer's Patients **Official Title:** 2-Hydroxybenzylamine (2-HOBA) Phase 1b/2a Proof-of Concept, Dose-Finding, Biomarker Study in Early Alzheimer's Patients #### Organization Study ID Info **ID:** MTI2024-CS01 #### Organization **Class:** INDUSTRY **Full Name:** MTI Biotech Inc #### Secondary ID Infos **Domain:** Alzheimer's Drug Discovery Foundation **ID:** RC-201910-2019696 **Type:** OTHER_GRANT **Domain:** VUMC IRB **ID:** IRB 231544 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Vanderbilt University Medical Center #### Lead Sponsor **Class:** INDUSTRY **Name:** MTI Biotech Inc #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Investigators propose a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250, 500, 750 mg 2-HOBA acetate TID or placebo for 16 weeks. Blood and cerebral spinal fluid (CSF) will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L. **Detailed Description:** This is a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250, 500, 750 mg 2-HOBA acetate TID or placebo for 16 weeks. Blood and CSF will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L. Investigators anticipate screening 120 subjects to randomize up to 60 subjects with the goal of 48 patients completing the study (allowing for up to 25% dropout) for the 16-week study. The primary aims of this project are to 1) Provide proof-of-concept that 2-HOBA protects proteins from covalent modification by inhibiting lysine-reacting dicarbonyls in the human brain. Investigators hypothesize that 16 weeks of 2-HOBA treatment will significantly reduce CSF levels of the dilysyl-MDA and IsoLG adduct of CSF proteins in a dose-responsive relationship. 2) Evaluate whether 2-HOBA is safe for extended use in patients with early AD. Investigators hypothesize that 2-HOBA will be safe and well tolerated through 16 weeks of use. Tolerability will be assessed by monitoring symptoms, adverse events, vital signs, ECG, and safety labs during the study. The secondary aims are to evaluate the effect of 2-HOBA treatment on AD biomarkers, brain inflammation, disease severity, and cognitive performance. ### Conditions Module **Conditions:** - Alzheimer Disease - Mild Cognitive Impairment **Keywords:** - Mild Cognitive Impairment - Alzheimer Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Treatment will be supplied in capsules of the same size and color. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Placebo treatment TID for 16 weeks. **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** 250 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks. **Intervention Names:** - Drug: 2-hydroxybenzylamine acetate **Label:** 250 mg 2-HOBA acetate **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** 500 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks. **Intervention Names:** - Drug: 2-hydroxybenzylamine acetate **Label:** 500 mg 2-HOBA acetate **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** 750 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 16 weeks. **Intervention Names:** - Drug: 2-hydroxybenzylamine acetate **Label:** 750 mg 2-HOBA acetate **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 250 mg 2-HOBA acetate - 500 mg 2-HOBA acetate - 750 mg 2-HOBA acetate **Description:** 2-hydroxybenzylamine acetate (2-HOBA) is taken three times per day for 16 weeks **Name:** 2-hydroxybenzylamine acetate **Other Names:** - 2-HOBA **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo taken three times per day for 16 weeks. **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Change in the total score for the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). **Measure:** Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) **Time Frame:** Baseline to Week 16 **Description:** For Activities of Daily Living (ADLs), the Alzheimer's disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale to assess the competence of participants in basic and instrumental ADLs will be utilized. A lower score indicates greater functional impairment. **Measure:** Activities of Daily Living (ADL) **Time Frame:** Baseline to Week 16 **Description:** The change participants' electrical brain activity will be monitored using noninvasive scalp electrodes. Event-related potentials (ERP), or time-locked EEG, will be used to evaluate cognitive processes. **Measure:** Quantitative Electroencephalography (EEG) **Time Frame:** Baseline to Week 16 #### Primary Outcomes **Description:** Rates of adverse events will be compared between active and placebo arms and presented as summary statistics. **Measure:** Safety/Tolerability (adverse events) **Time Frame:** Baseline to week 16 **Description:** Change in CSF levels of the dilysyl-malondialdehyde crosslink and the lysyl-levuglandin adduct of CSF proteins in a dose-responsive relationship **Measure:** Change in dicarbonyl protein adducts **Time Frame:** Baseline to week 16 #### Secondary Outcomes **Description:** Treatment compliance will be assessed through pill counts at Week 8 and 16 **Measure:** Compliance **Time Frame:** Baseline to week 16 **Description:** Change in phosphorylated-Tau-181 levels in CSF and plasma: **Measure:** Measurement of biomarker, p-Tau181 **Time Frame:** Baseline to week 16 **Description:** Change in plasma concentration of human cartilage glycoprotein 39 (YKL-4) **Measure:** Measurement biomarker, human cartilage glycoprotein 39 (YKL-4) **Time Frame:** Baseline to week 16 **Description:** Change in the concentration of neurofilaments light chain protein (NF-L) in CSF and plasma **Measure:** Measurment of biomarker, neurofilaments light chain protein (NF-L) **Time Frame:** Baseline to week 16 **Description:** Change in concentration F2-Isoprostanes in plasma and urine: **Measure:** Measurement of biomarker, F2-Isoprostanes **Time Frame:** Baseline to week 16 **Description:** Change in concentration of 8-hydroxy-2'-deoxyguanosine in plasma **Measure:** Measurement of biomarker, 8-hydroxy-2'-deoxyguanosine **Time Frame:** Baseline to week 16 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: MCI due to AD: 1. Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent. 2. Participant must have a subjective memory concern as reported by participant, study partner, or clinician. 3. Mini-Mental State Exam31 score between 24 and 30, inclusive 4. Clinical Dementia Rating (CDR)32 Global = 0.5. Memory Box score must be at least 0.5. Mild AD: 1. Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent. 2. Mild dementia of the Alzheimer's type according to the NIA-AA 2018 criteria. 3. CDR global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home \& hobbies, community affairs) Or CDR global score of 1.0 4. MMSE ≥20 Additional Inclusion Criteria for Both Diagnoses: 1. Age 55-85 (inclusive) 2. Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised: * Less than or equal to 11 for 16 or more years of education * Less than or equal to 9 for 8 - 15 years of education * Less than or equal to 6 for 0 - 7 years of education 3. Amyloid positivity established using the C2N Precivity2 Plasma test (Aβ42/40 plus p- tau217/np-tau217. (This test uses a statistical algorithm to integrate a patient's Aβ42/40 Ratio and p-Tau217 Ratio to calculate the Amyloid Probability Score 2 (APS2) and determines whether a patient is positive or negative for brain amyloid deposition based on a binary cutoff value). 4. Stable permitted medications for 4 weeks or longer as specified in Section 4.6.3, including: a. Memantine and cholinesterase inhibitors are allowable if stable for 12 weeks prior to screen. 5. Geriatric Depression Scale33 score of less than or equal to 14. 6. Study Partner is available who has frequent contact with the participant (e.g., an average of 10 hours per week or more) and can accompany the participant to most visits to answer questions about the participant. 7. Adequate visual and auditory acuity to allow neuropsychological testing. 8. Good general health with no additional diseases/disorders expected to interfere with the study. 9. Participant is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile). 10. Completed six grades of education or has a good work history. 11. Must speak English fluently. 12. Provide written informed consent. Participants must have the capacity to consent. Exclusion Criteria: 1. Any other significant neurologic disease including Parkinson's disease, multi- infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. 2. Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation, or behavioral problems within 3 months, which could lead to difficulty complying with the protocol. 3. History of schizophrenia (DSM V criteria). 4. History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria). 5. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic (Class C defined by Child-Pugh criteria), endocrine, or other systemic disease in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study. 6. Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment. 7. Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary, unless the required follow-up labs (homocysteine (HC) and methylmalonic acid (MMA) indicate that it is not physiologically significant. 8. Clinically significant abnormalities in screening laboratories or ECG. 9. Residence in a skilled nursing facility. 10. Use of any excluded medication as described in Section 6.10, including: * Use centrally acting anti-cholinergic drugs. * Use of any investigational drugs within 4 weeks or 5 half-lives, whichever is longer, prior to screening. 11. A current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening. 12. Contraindications for MRI studies, including claustrophobia, the presence of metal(ferromagnetic) implants, or cardiac pacemaker. 13. Participants whom the Site PI deems to be otherwise ineligible. **Maximum Age:** 85 Years **Minimum Age:** 55 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** John A. Rathmacher, Ph.D. **Phone:** 515-296-9916 **Role:** CONTACT #### Locations **Location 1:** **City:** Nashville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Amy R Boegel, Ph.D. - **Phone:** 615-875-0955 - **Role:** CONTACT ***Contact 2:*** - **Name:** Paul Newhouse, M.D. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Jason K Russell, VetMB, Ph.D. - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Alexander C Conley, Ph.D. - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Center for Cognitive Medicine, Vanderbilt University Medical Center **State:** Tennessee **Zip:** 37212 #### Overall Officials **Official 1:** **Affiliation:** Vanderbilt University Medical Center **Name:** Paul Newhouse, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** MTI Biotech Inc **Name:** John A. Rathmacher, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003704 - Term: Dementia - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000024801 - Term: Tauopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000003072 - Term: Cognition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Mild Cognitive Impairment - ID: M3885 - Name: Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M23002 - Name: Tauopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease ### Condition Browse Module - Meshes - ID: D000000544 - Term: Alzheimer Disease - ID: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432153 **Brief Title:** Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation **Official Title:** Tampa Scale of Kinesiophobia for Heart Taiwan Version Validation #### Organization Study ID Info **ID:** N_112_0424 #### Organization **Class:** OTHER **Full Name:** Changhua Christian Hospital ### Status Module #### Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-16 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Da-Yeh University #### Lead Sponsor **Class:** OTHER **Name:** Changhua Christian Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Early assessment of kinesiophobia in cardiovascular disease patients is essential. However, measurement tools are scarce for assessing activity fear in cardiovascular disease patients domestically. Currently, the Tampa Scale of Kinesiophobia for the Heart, developed by Bäck et al. (2012), is the most commonly used scale for measuring kinesiophobia among cardiovascular disease patients. As there is no tool available domestically to measure kinesiophobia in cardiovascular disease patients, this research aims to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and subsequently verify its reliability and validity for clinical assessment of kinesiophobia among cardiovascular disease patients. The methodology involves following the translation model by Jones et al. (2001) to translate the Tampa Scale of Kinesiophobia for Heart from the English version to the Taiwan version. Structured questionnaires, including demographic and disease-related information, the Tampa Scale of Kinesiophobia for Heart Taiwan Version, the International Physical Activity Questionnaire, the Six-Minute Walk Test, the Taiwan version of the World Health Organization Quality of Life Questionnaire-BREF, the Hospital Anxiety and Depression Scale, and the Pain Catastrophizing Scale will be used at the cardiological outpatient clinic and inpatient ward of a medical center in Central Taiwan. Patients meeting the study's inclusion criteria and consent to participate in this study will be interviewed. Tampa Scale of Kinesiophobia for Heart Taiwan Version will be examined for content validity, construct validity, internal consistency, and test-retest reliability. **Detailed Description:** Cardiovascular disease patients may avoid physical activity or exercise due to concerns that engaging in physical activities might exacerbate their heart condition or lead to injury. Interpretation of potential injury as a threat can induce kinesiophobia (fear of movement), causing patients to avoid physical activities, which could negatively impact both their physiological and psychological well-being. Previous research indicates a high prevalence of kinesiophobia among cardiovascular disease patients, and this fear negatively affects their physical activity performance, unwillingness to engage in cardiac rehabilitation, and worse quality of life. Therefore, early assessment of kinesiophobia in cardiovascular disease patients is essential. However, measurement tools are scarce for assessing activity fear in cardiovascular disease patients domestically. Currently, the Tampa Scale of Kinesiophobia for the Heart, developed by Bäck et al. (2012), is the most commonly used scale for measuring kinesiophobia among cardiovascular disease patients. As there is no tool available domestically to measure kinesiophobia in cardiovascular disease patients, this research aims to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and subsequently verify its reliability and validity for clinical assessment of kinesiophobia among cardiovascular disease patients. The objective of this study is to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and conduct reliability and validity verification. The methodology involves following the translation model by Jones et al. (2001) to translate the Tampa Scale of Kinesiophobia for Heart from the English version to the Taiwan version. A longitudinal study design will verify the validity and reliability of the Taiwan version of the Tampa Scale of Kinesiophobia for Heart. Structured questionnaires, including demographic and disease-related information, the Tampa Scale of Kinesiophobia for Heart Taiwan Version, the International Physical Activity Questionnaire, the Six-Minute Walk Test, the Taiwan version of the World Health Organization Quality of Life Questionnaire-BREF, the Hospital Anxiety and Depression Scale, and the Pain Catastrophizing Scale will be used at the cardiological outpatient clinic and inpatient ward of a medical center in Central Taiwan. Patients meeting the study's inclusion criteria and consent to participate in this study will be interviewed. Tampa Scale of Kinesiophobia for Heart Taiwan Version will be examined for content validity, construct validity, internal consistency, and test-retest reliability. The collected data will be analyzed using SPSS/PC version 22.0, and statistical methods such as frequency, percentage, mean, standard deviation, reliability analysis, Pearson correlation, and exploratory factor analysis will be used. This study aims to translate, revise, and establish the Taiwanese version of the Tampa Scale of Kinesiophobia for Heart and verify its reliability and validity for clinical assessment of Kinesiophobia among cardiovascular disease patients. It also aims to provide insight for future clinical research to analyze related factors further and develop intervention strategies, ultimately enhancing physical activity performance and quality of life and engaging in cardiac rehabilitation for cardiovascular disease patients. ### Conditions Module **Conditions:** - Cardiovascular Diseases **Keywords:** - Cardiovascular disease - Kinesiophobia - Scale reliability and validity ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The only group of participant. Participants are outpatient clinical patients diagnosed with cardiovascular disease. **Intervention Names:** - Other: observation **Label:** participant ### Interventions #### Intervention 1 **Arm Group Labels:** - participant **Description:** Participants who receive routine clinical care, without additional intervention from the study **Name:** observation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This scale, developed by Bäck et al. (2012), assesses fear of movement in patients with coronary artery disease. It comprises four dimensions: exercise avoidance, fear of injury, dysfunctional self-perception, and perceived risk of heart problems, with 17 items. Each item is scored on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), and items 4, 8, 12, and 16 are reverse scored. The total score ranges from 17 to 68, with higher scores indicating greater fear of movement. A TSK Heart score below 37 indicates a low fear of movement, while a score of 37 or higher indicates a high fear of movement. The scale's intra-class correlation coefficient is 0.83, and its internal consistency (Cronbach's alpha) is 0.78 (Bäck et al., 2012). **Measure:** Tampa Scale of Kinesiophobia for Heart **Time Frame:** baseline and at the end of the third month #### Secondary Outcomes **Description:** This study uses the short form of the Taiwan version of the IPAQ, developed in collaboration with Liu Ying-Mei and the World Health Organization. It consists of 7 items assessing physical activity over the past week across work, household chores, transportation, and leisure activities, including time and frequency of walking, moderate and vigorous activities, and time spent sitting. The total physical activity is calculated by multiplying each activity category by its corresponding Metabolic Equivalent (MET), execution time, and activity days. An IPAQ score below 600 indicates low physical activity, 600-3000 indicates moderate physical activity, and above 3000 indicates high physical activity. The scale's content validity is 0.994, and its intra-class correlation coefficient is 0.704 (Liou et al., 2008). **Measure:** International Physical Activity Questionnaire **Time Frame:** baseline and at the end of the third month **Description:** This test is commonly used in clinical settings to assess an individual's exercise capacity and endurance by measuring the distance walked in six minutes. During the test, participants are asked to walk as far as possible along a 30-meter corridor in six minutes. They can rest if they experience difficulty breathing (ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories, 2002). **Measure:** 6-Minute Walk Test **Time Frame:** baseline and at the end of the third month **Description:** Professor Yao Kai-Ping developed this questionnaire after obtaining authorization; this questionnaire assesses the quality of life across four domains: physical health, psychological well-being, social relationships, and environment, with 28 items. Each item is scored on a 5-point scale. Scores for each domain are calculated by averaging the scores of the items within that domain and multiplying by 4. Items 3, 4, and 26 are reverse-scored by subtracting the original score from 6. Higher scores indicate a better quality of life. The internal consistency is 0.91, and the content validity of the domains ranges from 0.51 to 0.64 (Taiwan WHOQOL Group, 2000; Yao Kai-Ping, 2002). **Measure:** Taiwan Brief Version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) **Time Frame:** baseline and at the end of the third month **Description:** This study uses the Chinese version of the HADS, translated by Chen Mei-Ling, initially developed by Zigmond and Snaith (1983). The scale consists of 14 items scored on a 4-point Likert scale (0 to 3), with separate scores for anxiety and depression. Each subscale has a total score range of 0 to 21, with higher scores indicating greater levels of anxiety or depression. **Measure:** Hospital Anxiety and Depression Scale (HADS) **Time Frame:** baseline and at the end of the third month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * (1) diagnosed with cardiovascular diseases by a specialist, including coronary artery disease, arrhythmia, valvular heart disease, and heart failure, with stable conditions; * (2) aged 18 or above; * (3) clear consciousness and able to communicate in Mandarin or Taiwanese; * (4) willing and consent to participate after being informed of the study purpose and procedures. Exclusion Criteria: * (1) cognitive impairment * (2) psychiatric disorders * (3) long-term bedridden patients who rely on others for daily activities. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** clinical patients diagnosed with cardiovascular diseases. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ai-Ling Chang, MSc **Phone:** +886-048336558 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Wan-Ting Huang, PhD **Phone:** +886-0953860172 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Changhua Christian Hospital **Name:** Ai-Ling Chang, MSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** No plans to share related information. **IPD Sharing:** NO ### References Module #### References **Citation:** ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. **PMID:** 12091180 **Citation:** Back M, Jansson B, Cider A, Herlitz J, Lundberg M. Validation of a questionnaire to detect kinesiophobia (fear of movement) in patients with coronary artery disease. J Rehabil Med. 2012 Apr;44(4):363-9. doi: 10.2340/16501977-0942. **PMID:** 22366980 **Citation:** Cakal B, Yildirim M, Emren SV. Kinesiophobia, physical performance, and health-related quality of life in patients with coronary artery disease. Postepy Kardiol Interwencyjnej. 2022 Sep;18(3):246-254. doi: 10.5114/aic.2022.122892. Epub 2022 Dec 17. **PMID:** 36751297 **Citation:** Keessen P, Kan KJ, Ter Riet G, Visser B, Jorstad H, Latour C, van Duijvenbode I, Scholte Op Reimer W. Impact of kinesiophobia on initiation of cardiac rehabilitation: a prospective cohort path analysis. BMJ Open. 2022 Nov 25;12(11):e066435. doi: 10.1136/bmjopen-2022-066435. **PMID:** 36428018 **Citation:** Jones PS, Lee JW, Phillips LR, Zhang XE, Jaceldo KB. An adaptation of Brislin's translation model for cross-cultural research. Nurs Res. 2001 Sep-Oct;50(5):300-4. doi: 10.1097/00006199-200109000-00008. **PMID:** 11570715 **Citation:** Liou YM, Jwo CJ, Yao KG, Chiang LC, Huang LH. Selection of appropriate Chinese terms to represent intensity and types of physical activity terms for use in the Taiwan version of IPAQ. J Nurs Res. 2008 Dec;16(4):252-63. doi: 10.1097/01.jnr.0000387313.20386.0a. **PMID:** 19061172 **Citation:** Lynn MR. Determination and quantification of content validity. Nurs Res. 1986 Nov-Dec;35(6):382-5. No abstract available. **PMID:** 3640358 #### See Also Links **Label:** WHOQOL BREF **URL:** https://www.semanticscholar.org/paper/Development-and-verification-of-validity-and-of-the-Yao-Chung/260271b00a65ac23b1324e52ef1597c13559f95d ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010698 - Term: Phobic Disorders - ID: D000001008 - Term: Anxiety Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M2922 - Name: Kinesiophobia - Relevance: HIGH - As Found: Kinesiophobia - ID: M13603 - Name: Phobic Disorders - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000092442 - Term: Kinesiophobia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432140 **Brief Title:** A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Severe AADC Deficiency **Official Title:** An Open, Dose-escalating and Dose Confirmation Trial to Evaluate the Safety and Efficacy of VGN-R09b by Intra Putamen Injection in Patients With Severe Aromatic L-amino Acid Decarboxylase (AADC) Deficiency #### Organization Study ID Info **ID:** VGN-R09b-102 #### Organization **Class:** INDUSTRY **Full Name:** Shanghai Vitalgen BioPharma Co., Ltd. ### Status Module #### Completion Date **Date:** 2030-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Shanghai Vitalgen BioPharma Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This trial includes dose-escalating part (phase 1) and dose confirming part, to prove the safety and efficacy of VGN-R09b to treat patients with severe AADC deficiency **Detailed Description:** Aromatic L-amino acid decarboxylase (AADC) is an enzyme responsible for the final step in the synthesis of neurotransmitters dopamine and serotonin. AADC deficiency is a rare genetic disorder. VGN-R09b is a kind of Gene therapy with adeno-associated virus (AAV) serotype 9 (AAV9) driven human AADC (hAADC) being injected directly into putamen. This is an open, dose-escalating and dose confirming study. The sponsor plans to explore two dose levels (6.0×1011vg and 1.28×1012vg) in dose-escalating phase (three subjects each cohort), then plans to have 10 subjects enrolled for dose confirmation phase. This study is to give evidence for the safety and efficacy of VGN-R09b treatment for patients with severe Aromatic L-amino acid decarboxylase (AADC) deficiency. ### Conditions Module **Conditions:** - Aromatic L-amino Acid Decarboxylase Deficiency **Keywords:** - AADC - AAV9 - Central Nervous System (CNS) gene therapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** VGN-R09b will be injected into bilateral putamen by stereotactic surgery ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Different levels of VGN-R09b will be injected into bilateral putamen by stereotactic surgery **Intervention Names:** - Genetic: VGN-R09b injection **Label:** VGN-R09b injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - VGN-R09b injection **Description:** Two levels of VGN-R09b will be injected into bilateral putamen in dose-escalating phase, and one dose level will be injected in dose confirming phase **Name:** VGN-R09b injection **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** Vital signs, physical examination, laboratory test will be monitored after drug injection **Measure:** Number of Adverse Events (AEs), Serious Adverse Events (SAEs) **Time Frame:** up to Week 52 **Description:** Four milestones, including Head control, Sit independently, Stand/stepping with support, Walk with minimal assistant, would be assessed according to definition in Peabody Developmental Motor Scale 2nd edition (PDMS-2) **Measure:** Number of subjects who achieved motor development milestones **Time Frame:** up to 24 months #### Secondary Outcomes **Description:** Increase in signal in the putamen and nigra on Fluorodopa-PET imaging as brain AADC activity measure **Measure:** Change in brain AADC activity **Time Frame:** up to 5 Years **Description:** Neurotransmitter metabolite concentrations of Homovanillic Acid/Hydroxyindoleacetic Acid (HVA/5-HIAA) would be measured **Measure:** Change in Cerebrospinal Fluid (CSF) neurotransmitter metabolite concentrations **Time Frame:** up to 5 Years **Description:** Motor function would be assessed by Peabody Developmental Motor Scale 2nd edition (PDMS-2) **Measure:** Change from baseline in motor function **Time Frame:** up to 5 Years **Description:** Number of disease related symptoms **Measure:** Change in number of Clinical symptoms **Time Frame:** up to 5 Years **Description:** Concentrations of Viral genome in serum/urine would be measured **Measure:** Viral shedding **Time Frame:** up to 1 week **Description:** Subject number with positive antibodies of AAV9/AADC/Glial Cell Line-Derived Neurotrophic Factor (GDNF) in blood would be reported **Measure:** Immunogenicity after injection **Time Frame:** up to 26 weeks **Description:** Drug-related AEs and SAEs would be monitored as long as 5 years after injection **Measure:** Number of Adverse Events (AEs), Serious Adverse Events (SAEs) in Long-term follow-up **Time Frame:** up to 5 Years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The child patient has to be ≥18 months old and \< 8 years old, and a head circumference big enough for surgery as judged by investigator. 2. Historical diagnosis of AADC deficiency with clinical symptoms consistency, AND with Molecular genetic confirmation of homozygous or compound heterozygous mutation point of IVS6+4A\>T in DDC gene. 3. With Plasma AADC activity less than or equal to 12 pmol/min/mL. 4. Motor development at baseline \<3 months (head fully uncontrollable at baseline）, and Failed to benefit from standard medical therapy (dopamine agonists, monoamine oxidase inhibitor or related form of Vitamin B6) at discretion of investigators. 5. Parent(s)/legal guardian(s) with custody of subject must give their consent for subject to enroll in the study. 6. Parent(s)/legal guardian(s) of the subject must agree to comply with the requirements of the study, including providing disease information and support disease assessment of symptoms. Exclusion Criteria: 1. Intracranial neoplasm or any structural brain abnormality or lesion (e.g., severe brain atrophy, white matter degenerative changes), which, in the opinion of the study investigators, would confer excessive risk and/or inadequate potential for benefit. 2. Presence of other significant medical or neurological conditions that would create an unacceptable operative or anesthetic risk (including congenital heart disease, respiratory disease with home oxygen requirement, history of serious anesthesia complications during previous elective procedures, history of cardiorespiratory arrest), liver or renal failure, malignancy, or HIV positive. 3. Severe coagulopathy, or need for ongoing anticoagulant therapy. 4. clinically active infection or with severe infection within 12 weeks before screening (e.g. adenovirus or herpes virus, pneumonia, sepsis, central nervous system infection). 5. Previous stereotactic neurosurgery, or any gene/cell therapy. 6. Received live vaccination within 4 weeks. 7. Contraindication to sedation during surgery or imaging studies (PET or MRI). **Maximum Age:** 8 Years **Minimum Age:** 18 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiumin Wang, MD **Phone:** +86-18017395221 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Shanghai Children's Medical Center, affiliated to Shanghai Jiao Tong University School of Medicine **Name:** Xiumin Wang, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T481 - Name: Aromatic L-amino Acid Decarboxylase Deficiency - Relevance: HIGH - As Found: Aromatic L-amino Acid Decarboxylase Deficiency ### Intervention Browse Module - Browse Branches - Abbrev: AnDyAg - Name: Anti-Dyskinesia Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7472 - Name: Dopa Decarboxylase - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432127 **Brief Title:** Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis **Official Title:** Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis in Patients With Failed Oral Prophylaxis Medication : A Randomized Controlled Study in Thailand #### Organization Study ID Info **ID:** 256/2024 #### Organization **Class:** OTHER **Full Name:** Mahidol University ### Status Module #### Completion Date **Date:** 2027-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mahidol University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this randomized controlled study in Thailand. is to find if there is a role of local anesthetic greater occipital nerve block at Cervical spine level 2 under ultrasound guide in prophylaxis of episodic migraine and chronic migraine in patients with failed oral prophylaxis medication. According to guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic and chronic migraine,the primary and secondary outcome were monitoring followed by these research guideline After informed consent, volunteer will be stratified random into 2 groups of injection agent at unilateral greater occipital nerve block on headache site under US guide by pain physician * Normal saline * 0.5% bupivacaine the injection was done 2 times between Week 0 and week 4 as to wean off placebo effect the volunteer will be monitor by pain diary at 1 month before intervention at week 0,4,8,12 and follow up at week 24 for Migraine Disability Assessment Test (MIDAS) ,Thai Hospital-Anxiety-depression index(Thai-HADS) **Detailed Description:** * Neurologist screening candidate volunteers for this study, following the inclusion and exclusion criteria * Candidate volunteers attended pain clinic for he protocol detail about this research and informed consent * After signing consent, Volunteers would be stratified randomization into 2 groups between Normal saline and bupivacaine * Volunteers would be done base line headache diary for 1 month before performing the procedure (Week -4 to week0) * At Week 0, Volunteers would be applied local anesthetic cream at skin injection site before done the procedure * According to stratified randomization, Pain interventionist and also volunteers would be blinded to the group * First Unilateral greater occipital nerve block at Cervical spine level 2 (C2) was done under ultrasound guide (Week0) * Telemedicine Follow up at week 2 * Second Unilateral greater occipital nerve block at C2 level was done under ultrasound guide (Week4) * Volunteers would be follow up via telemedicine and done headache diary until 3 months after 1st injection * Volunteers would be follow up according to outcome monitoring protocol in Week 0,4,8,12,24 ### Conditions Module **Conditions:** - Migraine Disorders ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 108 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Use Normal saline 3 ml as the injection agent **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Use 0.5% Bupivacaine 3ml as the injection agent **Intervention Names:** - Drug: Bupivacaine **Label:** Bupivacaine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Placebo **Description:** Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL **Name:** Placebo **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Bupivacaine **Description:** Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL **Name:** Bupivacaine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** by using headache diary **Measure:** change of Frequency headache day /month **Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure **Description:** by using headache diary **Measure:** change of migraine attack day /month from headache diary **Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure #### Secondary Outcomes **Description:** decrease of moderate-severe pain day per month compare to baseline by using headache diary **Measure:** change in severity of headache day per month (decrease of moderate-severe pain) **Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure **Description:** Thai-Migraine Disability Assessment (MIDAS) ,Score 0 to 21+ ( 0-5 marks = little or no disability and more than 21+ =severe disability **Measure:** Thai-Migraine Disability Assessment **Time Frame:** at Week 12,24 compare to baseline **Description:** Thai-Hospital Anxiety and Depression Scale (Thai HADS) , divided into anxiety and depression part ,if either of the score in each depression or anxiety more than 11 mean abnormal **Measure:** Thai-Hospital Anxiety and Depression Scale **Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure **Description:** by EuroQoL- (EQ-5D) measured health-related quality of life with 5 dimension (mobility, health care, usual activity, Pain, Anxiety/depression and in each of them had 5 grading 1-5 by 1 means no problem and 5 means extreme problem) after having score in each dimension, calculated utility score would be done **Measure:** Healthcare outcomes/quality of life **Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure **Description:** Patient's reported outcome measurement (PGI-C), score grading 1-7 by 1 very much worse to very much improved , 7 means very much worse **Measure:** Patient's reported outcome measurement (PGI-C) **Time Frame:** at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18 -65 years old 2. Diagnosis as episodic migraine or chronic migraine and had indication to use migraine prophylaxis 3. Volunteer prefer to use research procedure as first choice of migraine prophylaxis 4. Volunteer already had migraine prophylaxis treatment but still has the one of these following problem 4.1 Frequency of migraine attack more than 4 times/month 4.2 Severe migraine headache \& disturb daily life in spite of using migraine prophylaxis 4.3 Having migraine medication side effect, either from prophylaxis or acute attack medication and cannot titration medication dosage 4.4 migraine attack not improved as using many migraine prophylaxis medications 4.5 Having contra-indication to use prophylaxis migraine medication or standard prophylaxis procedure such as botulinum toxin 4.6 Cannot take prophylaxis medication daily (low compliance) 4.7 Had financial problems in using standard prophylaxis migraine medication or procedure 4.8 Medication overuse headache Exclusion Criteria: 1. Had these type of headache in combination with migraine * cervicogenic headache * occipital neuralgia * secondary headache 2. Had contraindication on greater occipital nerve block injection at cervical spine level 2 under ultrasound-guided such as skin infection in needle site 3. Allergy to local anesthetic 4. Uncontrolled psychiatric disorder in 3 months before attending research 5. Cannot understand or reading, writing Thai language **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** RAVIWON ATISOOK, M.D. **Phone:** +66819140784 **Role:** CONTACT #### Locations **Location 1:** **City:** Bangkok **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Raviwon Atisook, M.D - **Phone:** +66819140784 - **Role:** CONTACT **Country:** Thailand **Facility:** Raviwon Atisook **Zip:** 10700 #### Overall Officials **Official 1:** **Affiliation:** Siriraj Hospital **Name:** RAVIWON ATISOOK, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** will be consider again after data collection **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M9351 - Name: Headache - Relevance: HIGH - As Found: Headache - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders - ID: D000006261 - Term: Headache ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: HIGH - As Found: Following - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002045 - Term: Bupivacaine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432114 **Brief Title:** Sensory Awareness Program **Official Title:** Coping Through Sensory Modulation. A Sensory Awareness Program (SAP) for Reducing Anxiety and Mobilizing Coping Strategies for People With Severe Mental Health Problems. A Randomized Controlled Trial. #### Organization Study ID Info **ID:** SAP #### Organization **Class:** OTHER **Full Name:** Lund University ### Status Module #### Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Start Date **Date:** 2022-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-17 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lund University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Few alternatives to addictive medical treatment exists for persons with severe mental health problems (SMHP) and anxiety, often connected to high risk of suicide. Access to effective interventions that depart in individuals' needs to cope with anxiety in everyday life is crucial to provide and desperately warranted by service users. Service users are often unaware of sensory needs, connected to anxiety outburst. The Sensory Awareness Program (SAP) is a group-based self-management intervention of 10 weeks developed to meet complex needs of regulating anxiety and related self-destructive behaviors. SAP stems from theories on sensory modulation and is an approach to manage physiological arousal associated with anxiety through self-regulated sensory-based coping strategies. International research show that sensory modulation is effective both as a method to reduce anxiety and thus restraint in acute mental health services (MHS), and also to empower users. However, much research to date focus on using sensory strategies within wards. International research and pre-studies of testing the SAP in outpatient MHS indicate that it is a promising self-management intervention to support everyday life. Earlier studies further show that users' unawareness of sensory needs triggers anxiety, and that anxiety itself is the main contributing factor for disrupting everyday life. Also, staff acknowledge sensory modulation but lack knowledge on whether programs such as SAP is effective and possible to implement. The overall aim is to investigate the effectiveness of SAP as compared to treatment as usual (TAU) among 200 outpatients. The investigators hypothesize that SAP will be more effective than TAU in terms of reduced anxiety (primary outcome) at three months follow-up. Secondary clinical and personal recovery outcomes post intervention and at three and six months follow up will also be targeted and assumed to be in favour of the SAP group. The implementation process of the SAP will also be explored. ### Conditions Module **Conditions:** - Anxiety ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Sensory Awareness Program (SAP) - Other: Treatment as usual (TAU) **Label:** Sensory Awareness Program **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Treatment as usual (TAU) **Label:** Treatment as usual **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Sensory Awareness Program **Description:** SAP is a new rehabilitation program for people with severe mental health problems. SAP aims to help the target group manage anxiety outburst and live an active life through sensory modulation techniques. **Name:** Sensory Awareness Program (SAP) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Sensory Awareness Program - Treatment as usual **Description:** Treatment as usual is standard psychiatric care for the target group. **Name:** Treatment as usual (TAU) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Beck Anxiety Inventory (BAI) is a self-report questionnaire measuring the severity of anxiety symptoms with 21 questions, each describing a symptom of anxiety. The participant rates each item on a scale from 0 to 3, indicating how much he/she experiences each symptom. The scores range from 0 to 63, with higher scores indicating more severe levels of anxiety. **Measure:** Becks anxiety inventory (BAI) **Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months #### Secondary Outcomes **Description:** The Hopkins Symptoms Checklist (HSCL-25) is a widely used screening instrument with 25 items measuring symptoms of anxiety and depression. The scale for each question includes four response categories from 1 (not at all) to 4 (very much). The total score is the average of all 25 items. **Measure:** Hopkins Symptom Checklist-25 (HSCL-25) **Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months **Description:** The Difficulties in Emotion Regulation Scale (DERS) is a self-report measure of emotion regulation difficulties. The total score ranges from 16-80 with higher scores indicating more difficulties with emotion regulation. **Measure:** Difficulties in Emotion Regulation scale (DERS) **Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months **Description:** The Brief-COPE is an instrument reflecting individuals' coping strategies when exposed to a stressful situation. Brief-COPE is the short version and consists of 14 sub-scales, with 2 items in each scale, with a total of 28 items. The items are rated on a scale from 1 (seldom) to 4 (very often). In the current study, we will use the three-factor model of the instrument where the 14 subscales are divided into 3 factors; 'Problem-focused coping', 'Emotion-focused coping' and 'Avoidant coping'. **Measure:** Coping Orientation of Problem Experience Inventory (COPE) **Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months **Description:** The Manchester Short Assessment of Quality of Life (MANSA) consists of 16 questions, covering different domains of life such as physical health, social relationships, employment, and overall life satisfaction. Each question is rated on a scale from 1 to 7, with higher scores indicating better quality of life. **Measure:** Manchester Short Assessment of Quality of Life Scale (MANSA) **Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months **Description:** The Pearlin Mastery Scale is used to assess an individual's perceived sense of control over their life circumstances, containing seven questions to rate the level of agreement with statements about the ability to control and influence life. It covers areas such as personal growth, problem-solving, and self-mastery and is rated on a scale from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating greater levels of mastery. **Measure:** Pearlin Mastery Scale **Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months **Description:** The Process of Recovery Questionnaire (QPR-7) is a short version of the instrument with 15 items (Argentzell et al., 2017). QPR-7 has seven questions concerning which aspects of recovery have been meaningful for the participants on a five-graded scale from 0 (disagree strongly) to 4 (agree strongly). **Measure:** Process of Recovery Questionnaire (QPR-7) **Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months **Description:** POES is an instrument that helps to discern the level of occupational engagement. The POES has two parts, one being the 24-hour yesterday time use diary and a second part consisting of a self-rated questionnaire with 9 items representing different components of occupational engagement. Based on the time diary the participants reflect on the content and rate to what extent it corresponds to a lower or higher level of occupational engagement on a 4-point scale. **Measure:** Profiles of Occupationa Engagement (POES) **Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months **Description:** The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a questionnaire used to assess an individual's perceived level of functioning and disability across six domains of life with 12 questions covering: activities and participation in society. Each question is rated on a scale from 0 to 4, with higher scores reflecting greater levels of disability. **Measure:** The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) **Time Frame:** Before intervention, post intervention (at 3 months), 6 and 9 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Be assigned to a MHS * Age over 18 * Having SMHP (including a diagnosis of mood disorder, anxiety disorder, eg PTSD, panic disorder etc, and/or psychotic disorder) * Experience anxiety Exclusion Criteria: * Acutely mentally unwell * Cognitively impaired * Non-Swedish speaking **Gender Based:** True **Gender Description:** Male, female, non-binary **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Elisabeth Argentzell, PhD **Phone:** +46702933552 **Role:** CONTACT #### Locations **Location 1:** **City:** Helsingborg **Contacts:** ***Contact 1:*** - **Name:** Jenny Ericsson - **Role:** CONTACT **Country:** Sweden **Facility:** Region Skåne **Status:** RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432101 **Brief Title:** Acupuncture Combined With Hydroxychloroquine **Official Title:** Clinical Efficacy of Acupuncture Combined With Hydroxychloroquine Sulfate Tablets in Improving Oral and Ocular Dryness in Primary Sjögren's Syndrome #### Organization Study ID Info **ID:** [email protected] #### Organization **Class:** OTHER **Full Name:** Heilongjiang University of Chinese Medicine ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Senyue Zhang #### Responsible Party **Investigator Affiliation:** Heilongjiang University of Chinese Medicine **Investigator Full Name:** Senyue Zhang **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To observe the clinical efficacy of acupuncture combined with hydroxychloroquine sulfate tablets on the symptoms of dry mouth and dry eyes in primary Sjögren's syndrome. **Detailed Description:** Methods: Seventy-two patients with primary Sjögren's syndrome who met the inclusion criteria were randomly divided into the experimental group (36 patients, 3 patients who fell out) and the control group (36 patients, 4 patients who fell out). The control group was treated with oral hydroxychloroquine sulfate tablets alone, 0.2g each time, taken twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment, and the experimental group was treated with acupuncture treatment on the basis of the control group, acupuncture once a day, acupuncture for 5 days and 2 days of rest, 4 weeks for 1 course of treatment, a total of 2 courses of treatment. The changes in the outcome indicators of the two groups before and after treatment were observed, and the main outcome indicators included salivary flow rate (SFR) and Schirmer test. Secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient-Reported Index (ESSPRI), the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and laboratory measures (ESR, CRP, IgG). ### Conditions Module **Conditions:** - Primary Sjögren's Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 65 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Acupuncture combined with oral hydroxychloroquine sulfate tablets **Intervention Names:** - Other: Acupuncture combined with oral hydroxychloroquine sulfate tablets **Label:** acupuncture combined with hydroxychloroquine sulfate tablets **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Oral hydroxychloroquine sulfate tablets (Shanghai Shangyao Sino-Western Pharmaceutical Co., LTD., Fenle, Sinopyma approval number H19990263, 0.1g x 14 tablets) were treated with 0.2g each time, twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment. **Label:** oral hydroxychloroquine sulfate tablets **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - acupuncture combined with hydroxychloroquine sulfate tablets **Description:** Acupuncture combined with oral hydroxychloroquine sulfate tablets **Name:** Acupuncture combined with oral hydroxychloroquine sulfate tablets **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Used to evaluate the salivary flow rate of pSS patients before and after treatment. Before the start of the experiment, the patient gargled with water to keep the mouth clean and free of irritation. Saliva collected at the bottom of the mouth and spit it into the measuring cup every 1min. After collecting it for 10min, the value was recorded. The less the saliva flow rate within 10 minutes, the worse the symptoms, and less than 1ml is abnormal. **Measure:** Salivary flow rate (Sauf) **Time Frame:** 8 weeks **Description:** Used to evaluate the degree of tear secretion in pSS patients before and after treatment. The 5mm×35mm filter paper was folded at a right Angle at 5mm from one end, and the end was placed in the conjunctival sac at 1/3 of the outer eyelid of the patient. The eyes were closed and the clamp was held for 5min, and the wet length of the filter paper was measured, and the filter paper was positive if it was less than 5mm/5min. The less tears are secreted within five minutes, the more severe the symptoms. **Measure:** Schirmer test **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** Used to assess the degree of dryness, pain, and fatigue in pSS patients, it is an evaluation of disease activity based on patients' subjective feelings. On a scale of 0 to 10 from mild to severe, the final ESSPRI score is the average score of dryness, pain and fatigue. Scores \<5 were classified as acceptable symptom status and \>5 as unsatisfactory symptom status. **Measure:** Sjögren's syndrome patient-reported index (ESSPRI) **Time Frame:** 8 weeks **Description:** used to evaluate disease activity in patients with pSS, ESSDAI is an evaluation of disease activity based on objective facts. The score weight includes 12 dimensions, including systemic symptoms, lymph node disease, glandular disease, joint disease, skin disease, peripheral neuropathy, central neuropathy, lung disease, kidney disease, muscle disease, hematological diseases and serological changes. The total score of ESSDAI is equal to the sum of the score of the severity of each system × the product of the weight of the system. A scale of \<5 was classified as low disease activity, 5 to 13 as moderate disease activity, and \>14 as high disease activity. **Measure:** EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical diagnosis of primary Sjögren's syndrome * Must be able to receive acupuncture treatment and swallow tablets Exclusion Criteria: * Patients with malignant tumors or severe organ function impairment * Patients who are lactating or pregnant. * Persons who are participating in clinical trials of other drugs. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Harbin **Country:** China **Facility:** Senyue Zhang **State:** Heilongjiang **Zip:** 150040 #### Overall Officials **Official 1:** **Affiliation:** Heilongjiang University of Chinese Medicine **Name:** Senyue Zhang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000001172 - Term: Arthritis, Rheumatoid - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000014987 - Term: Xerostomia - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000007766 - Term: Lacrimal Apparatus Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M15664 - Name: Sjogren's Syndrome - Relevance: HIGH - As Found: Sjogren's Syndrome - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M17724 - Name: Xerostomia - Relevance: LOW - As Found: Unknown - ID: M15285 - Name: Salivary Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M18040 - Name: Dry Eye Syndromes - Relevance: LOW - As Found: Unknown - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012859 - Term: Sjogren's Syndrome - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Ancestors - ID: D000000962 - Term: Antimalarials - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018501 - Term: Antirheumatic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9940 - Name: Hydroxychloroquine - Relevance: HIGH - As Found: Consider - ID: M4280 - Name: Antimalarials - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006886 - Term: Hydroxychloroquine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432088 **Brief Title:** Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device **Official Title:** Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device #### Organization Study ID Info **ID:** LVT009 #### Organization **Class:** INDUSTRY **Full Name:** Levita Magnetics #### Secondary ID Infos **Domain:** Levita Magnetics **ID:** CP009 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-13 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Levita Magnetics #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. **Detailed Description:** The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures. ### Conditions Module **Conditions:** - Bariatric Surgery Candidate - Hiatal Hernia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. **Intervention Names:** - Device: Extended Magnetic Grasper Device **Label:** Extended Magnetic Grasper Device **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Extended Magnetic Grasper Device **Description:** The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. **Name:** Extended Magnetic Grasper Device **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity. **Measure:** Adverse Events **Time Frame:** 30 days **Description:** Ability to adequately mobilize the liver to achieve an effective exposure of the target tissue. Adequate mobilization is not achieved if it is necessary to use another liver retractor during the procedure. **Measure:** Mobilization **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * At least 18 years of age. * Scheduled to undergo elective bariatric and/or hiatal hernia procedures. * Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures. Exclusion Criteria: * Individuals with pacemakers, defibrillators, or other electromedical implants. * Individuals with ferromagnetic implants. * American Society of Anesthesiologists (ASA) score of III or IV. * Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure). * Clinical history of impaired coagulation confirmed by abnormal blood tests. * Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.). * Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use. * Pregnant or wishes to become pregnant during the length of study participation. * Individual is not likely to comply with the follow-up evaluation schedule. * Participating in a clinical trial of another investigational drug or device. * Prisoner or under incarceration. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Vivian Soto **Phone:** +56958360507 **Role:** CONTACT #### Locations **Location 1:** **City:** Santiago **Contacts:** ***Contact 1:*** - **Name:** Julio Jimenez Lillo - **Phone:** +56 2 2472 5690 - **Role:** CONTACT **Country:** Chile **Facility:** Hospital Santiago Oriente Dr. Luis Tisné Brousse **State:** Metropolitana **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006547 - Term: Hernia - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000006548 - Term: Hernia, Diaphragmatic - ID: D000082122 - Term: Internal Hernia ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9629 - Name: Hernia, Hiatal - Relevance: HIGH - As Found: Hiatal Hernia - ID: M9625 - Name: Hernia - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M9626 - Name: Hernia, Diaphragmatic - Relevance: LOW - As Found: Unknown - ID: M2344 - Name: Internal Hernia - Relevance: LOW - As Found: Unknown - ID: M25675 - Name: Hernia, Abdominal - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006551 - Term: Hernia, Hiatal ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432075 **Brief Title:** Neoantigen Reactive T Cells c for Chinese Patients With Advanced Gastric Cancer **Official Title:** Single Arm Clinical Prospective Study of Neoantigen Reactive T Cells (NRTs) in the Treatment of Chinese Patients With Advanced Gastric Cancer #### Organization Study ID Info **ID:** Neoantigen T Cells #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital of Wenzhou Medical University ### Status Module #### Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital of Wenzhou Medical University #### Responsible Party **Investigator Affiliation:** First Affiliated Hospital of Wenzhou Medical University **Investigator Full Name:** Shen Xian **Investigator Title:** Chief Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to see the safety and efficient of neoantigen reactive T cells (NRTs) in the treatment of Chinese patients with advanced gastric cancer. **Detailed Description:** The tumor-specific "none-self" immunogenic neoantigens encoded by either viral genes or somatic mutation genes, possess the potential to induce specific anti-cancer immunity, including cellular and humoral immune responses. Today, numerous clinical trials demonstrate that although these "none-self" antigens initiate the antigen-specific immunoglobulin G antibodies and cluster of differentiation 4（CD4）+/cluster of differentiation 8（CD8）+T-cells response, not all of them show a clinical benefit in the response rate, progression-free survival or overall survival.Personalized cell therapy maybe own a breakthrough in the treatment of those gastric cancer patients without standard options.The investigators' center has successfully established a new method for preparing personalized neoantigen reactive T cells(NRTS) for adoptive cell therapy(ACT). Today, the investigators will carry out a single arm clinical prospective study of NRTs for the treatment of Chinese patients with advanced gastric cancer. Participants are assigned to receive 4 circles of cell therapy, and IL-2 continuous intravenous infusion（CIV） will also be given for 5 consecutive days after each time's cell infusion. The safety and clinical response rate（RR） are evaluated. Biomarkers and immunological markers are also monitored. ### Conditions Module **Conditions:** - Advanced Gastric Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory;nab-paclitaxel 100-200mg/m2/D will be i.v. for 7 days before cell infusion; Cyclophosphamide 300mg/m2/D will be i.v. for 2 and 3 days before cell infusion; NRTs 0.5\~1 x 10\^10, will be i.v.Q3 weeks for total 4 doses;Interleukin-2 (IL-2) will be continuous intravenous infused since the first day of the cell infusion for 5 consecutive days, 1000,000 international unit per day.All Patients will receive a total of 4 cycles of treatment. **Intervention Names:** - Biological: Neoantigen Reactive T Cells(NRTs) **Label:** Neoantigen Reactive T Cells **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Neoantigen Reactive T Cells **Description:** Neoantigen Reactive T Cells in an expected volume of 100 milliliter（mL） will be given by intravenous injection over 2-10 minutes through either a peripheral or a central line. **Name:** Neoantigen Reactive T Cells(NRTs) **Type:** BIOLOGICAL ### Outcomes Module #### Other Outcomes **Description:** the duration is measured from the time of treatment to the time of death **Measure:** Overall Survival (OS) **Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months **Description:** T cells in the peripheral blood stimulated by tumor antigens for 24 hr，and then Interferon-gama secretion is measured **Measure:** Interferon-gama change of PBMC cells in the peripheral blood stimulated by tumor antigens **Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months #### Primary Outcomes **Description:** using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients **Measure:** Number of participants with Adverse Events **Time Frame:** up to 6 months #### Secondary Outcomes **Description:** Response Rate（RR）will be evaluated according Response Evaluation Criteria in Solid Tumors **Measure:** Response Rate **Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months **Description:** the duration of progression free survival is measured from the time of treatment to the first date that recurrent or progressive disease or for any reason of death is objectively documented. **Measure:** Progression free survival (PFS) **Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Voluntarily join the study and sign the informed consent; 2. Age: 18-75 years old, male or female; 3. Subjects with advanced gastric cancer who had received systematic standard treatment before enrollment and had no effective treatment at present. (Note: The effective treatment means refer to the latest version of the "Gastric Cancer Diagnosis and Treatment Guide" issued by China's "Chinese Clinical Oncology Society".) ; 4. Have at least one measurable lesion according to imRECIST evaluation criteria; 5. Expected survival ≥5 months (starting from the collection of tissue samples for sequencing); 6. The Eastern Cancer Consortium (ECOG) score was 0 or 1 or 2; 7. The following hematological indicators should be met: neutrophil count ≥ 1.5×109/L; Hemoglobin ≥ 10.0 g/dL; Platelet count ≥ 50×109/L; 8. The following biochemical indicators should be met: total bilirubin ≤2.0× upper limit of normal value (ULN); AST and ALT ≤2.0×ULN; Serum creatinine ≤1.5×ULN. 9. Before lymphocyte clearance preadministration: 1) any chemotherapy, small molecule targeted drugs and other antitumor therapy received have passed the 3-week washout period, and the toxic side effects have returned to grade 1 or lower (excluding hair loss, vitiligo and other events as determined by the investigator to be tolerated); 2) If surgical treatment is performed within 3 weeks, toxicity has returned to grade 1 or lower; 3) The immunotoxicity of major organs has returned to grade 1 or lower after receiving any antibody drug treatment, and the washout period of PD-1 antibodies has reached 6 weeks, and CTLA-4 antibodies and other antibodies have passed the washout period of 4 weeks. Exclusion Criteria: 1. Subjects infected with HBV, HCV, HIV, syphilis and tuberculosis; 2. Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or what the investigator considers Other diseases not included in the group; 3. Patients with a history of bone marrow or organ transplantation; Patients with coagulation dysfunction; 4. Patients with immune deficiency diseases or autoimmune diseases who are treated with immunosuppressive drugs; 5. Central nervous system (CNS) metastatic and/or cancerous meningitis; 6. People who may be allergic to immunotherapy; 7. Drug abuse, clinical or psychological or social factors that affect informed consent or the conduct of the study; 8. Pregnant and lactating women; 9. Participating in other clinical trials; 10. An uncertainty that the investigator believes has an impact on the subject's safety or compliance. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xian Shen **Phone:** 13968888872 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** Publications **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: HIGH - As Found: Gastric Cancer ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M6727 - Name: Cyclophosphamide - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M10411 - Name: Interleukin-2 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432062 **Brief Title:** Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia **Official Title:** Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia #### Organization Study ID Info **ID:** 2022-13596 #### Organization **Class:** OTHER **Full Name:** Istanbul Saglik Bilimleri University ### Status Module #### Completion Date **Date:** 2024-05-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-04-15 **Type:** ACTUAL #### Start Date **Date:** 2023-09-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Saglik Bilimleri University #### Responsible Party **Investigator Affiliation:** Istanbul Saglik Bilimleri University **Investigator Full Name:** Hatice Karabulut **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The rectus abdominis, which enables the trunk to flex with its activation, and the erector spinae muscles, which provide trunk extension with its activation, are among the structures located in the core region and involved in the stabilization of the spine. While the muscles in the core area actively provide the stabilization of the medulla spinalis, this stabilization is also supported by passive subsystems. Passive subsystem fascia etc. creates structures. Thoracolumbar fascia is one of the important fascias due to its connections with the muscles in the core area. Fatigue etc. of the structures in the core area. As a result of physiological processes, their functionality may decrease, which may affect the stabilization of the core area. Fatigue occurs as a result of lactic acid accumulation in the structures in the body and this process is called the recovery period. The types of exercises performed also affect the recovery period. For this reason, different exercise types such as dynamic and static can be used when creating exercise programs. Due to the functions of the rectus abdominis and erector spinae muscles and thoracolumbar fascia in the body, their effects on the spine and their connections with each other; It is aimed to examine the effect of muscle fatigue in these muscles on the viscoelastic properties of the thoracolumbar fascia and their recovery rates. ### Conditions Module **Conditions:** - Muscle Weakness **Keywords:** - rectus abdominis - erector spinae - thoracolumbar fascia ### Design Module #### Design Info **Observational Model:** CASE_CROSSOVER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Viscoelastic properties of the thoracolumbal fascia (TFL) was performed with the MyotonPRO™ (Myoton AS, Estonia) device. Before and after imeddiately after application of the fatigue protocol. The measurement point determined for TFL of individuals rest were marked with a medical marker pen. During the measurement, the probe of the device was adjusted to pulse once into the skin with a force of 0.4 N and for 15 ms. During the test, the tip of the MyotonPro™ device was placed perpendicular to the marked area and gently pressed against the skin at a depth of 3 mm until the green light came on. **Measure:** Thoracolumbal Fascia Viscoelastic Properties **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** Fatigue assessment will be made using the Modified Borg Scale. The Modified Borg Scale is a subjective evaluation method that evaluates fatigue and shortness of breath during activity or at rest between 0 and 10. 0 points "not at all" means the lowest, and 10 points "very severe" means the highest fatigue and shortness of breath. **Measure:** Fatigue Assessment with Borg Scale **Time Frame:** 2 weeks **Description:** Moxy®, (Moxy®, Fortiori Design LLC, Minnesota, USA) Monitor will be used to detect the change in intramuscular oxygen saturation of the muscles and the time it takes to return to resting levels during and after fatigue protocols. The most swollen areas of the rectus abdominis and erector spinae muscles will be marked with a cosmetic pen and the device will be placed. **Measure:** Investigations of Recovery Times **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being a healthy individual between the ages of 18-35 * Not having any chronic disease * Body mass index (BMI) is 24.9 kg/m2 or lower * Volunteering to participate in the study Exclusion Criteria: * Having a chronic illness (Diabetes, blood pressure, etc.) * Having a diagnosed spine problem * Being diagnosed with scoliosis * Pilates, yoga, etc. in the last 6 months. to have done sports * Beighton score of 4 or above * Being diagnosed with cardiopulmonary system disease **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** MALE **Standard Ages:** - ADULT **Study Population:** This study will be conducted with healthy male individuals between the ages of 18-35. Individuals without any orthopedic, neurological or chronic disease will be included in the study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Istanbul Health Science University **State:** Uskudar ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Muscle Weakness - ID: M13204 - Name: Paresis - Relevance: LOW - As Found: Unknown - ID: M4554 - Name: Asthenia - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018908 - Term: Muscle Weakness ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432049 **Brief Title:** Endocrown Restoring First Permanent Molar in Children **Official Title:** Clinical and Radiographic Outcome of Endocrown Restoring First Permanent Molar in Children: Clinical Randomized Study #### Organization Study ID Info **ID:** MKSU/22-11-4 #### Organization **Class:** OTHER **Full Name:** Kafrelsheikh University ### Status Module #### Completion Date **Date:** 2024-05-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-09 **Type:** ACTUAL #### Start Date **Date:** 2022-12-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kafrelsheikh University #### Responsible Party **Investigator Affiliation:** Kafrelsheikh University **Investigator Full Name:** Ahmed Ismail Taha **Investigator Title:** lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months **Detailed Description:** This study comprised 30 children, with age range of (10-13) years old, with endodontically treated first permanent molars. Participants were classified into three groups according to type and material of the final restoration. All selected children were assigned to either PMC group (n=10) restored with performed metal crowns (Stainless-steel Molar Crowns) , EMX group (n=10) endocrown fabricated from CAD-CAM lithium disilicate glass ceramic , COP group (n=10) endocrown fabricated from CAD-CAM reinforced composite. After cementation, all children were evaluated over one year; at one week post-operative, 6 and 12 months for the following criteria: radiographic findings, plaque index, periodontal index, parent satisfaction. ### Conditions Module **Conditions:** - Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in Children **Keywords:** - Endocrown - CAD-CAM - Children - Ceramic - Molars ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** endodontically treated molar restored with Stainless steel crown **Intervention Names:** - Other: restoration for endodontically treated molar **Label:** PMC **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** endodontically treated molar restored with endocrown fabricated from CAD-CAM lithium disillicate **Intervention Names:** - Other: restoration for endodontically treated molar **Label:** EMX **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** endodontically treated molar restored with endocrown fabricated from CAD-CAM composite **Intervention Names:** - Other: restoration for endodontically treated molar **Label:** COP **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - COP - EMX - PMC **Description:** prefabricated stainless steel crown or endocrown **Name:** restoration for endodontically treated molar **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings **Measure:** number of participants with pathological changes in radiographs **Time Frame:** 6 months **Description:** evaluation of the extent of parent satisfaction with different type of restorations using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree. **Measure:** degree of parent satisfaction with different restorations **Time Frame:** 6 month **Description:** plaque index evaluate the plaque accumulation around different type of restorations. this index involves: * Plaque index 0: No plaque is in the area adjacent to the gingiva. * Plaque index 1: There is a plaque in the form of a thin film on the gingival margin. * Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin. * Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin. **Measure:** rate of plaque accumulation on different type of restorations **Time Frame:** 6 months **Description:** gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding. **Measure:** effect of different restoration on surrounding gingiva **Time Frame:** 6 months #### Secondary Outcomes **Description:** periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings **Measure:** number of participants with pathological changes in radiographs **Time Frame:** 1 year **Description:** using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree. **Measure:** degree of parent satisfaction with different restorations **Time Frame:** 1 year **Description:** plaque index evaluate the plaque accumulation around different type of restorations. this index involves: * Plaque index 0: No plaque is in the area adjacent to the gingiva. * Plaque index 1: There is a plaque in the form of a thin film on the gingival margin. * Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin. * Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin. **Measure:** rate of plaque accumulation on different type of restorations **Time Frame:** 1 year **Description:** gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding. **Measure:** effect of different restoration on surrounding gingiva **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient age ranging from 10-13 years old with closed apex. * Normal occlusion without any para-functional habits. * Decayed lower first molar. * Supra-gingival margin was required after preparation. * Absence of root fractures or cracks. Exclusion Criteria: * Difficulty to apply rubber dam for proper endocrown bonding. * Lack of patient cooperation for post-operative recall and follow up. * Bad oral hygiene **Maximum Age:** 13 Years **Minimum Age:** 10 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Kafr Ash Shaykh **Country:** Egypt **Facility:** Kafr El Shaikh University **Zip:** 6860404 ### IPD Sharing Statement Module **Description:** all data will be shared after publishing. **IPD Sharing:** UNDECIDED ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19022 - Name: Lithium Carbonate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432036 **Brief Title:** Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial **Official Title:** RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open-Label, Prospective, Multi-Center, Phase 1/2 Safety Trial #### Organization Study ID Info **ID:** 23-001261 #### Organization **Class:** OTHER **Full Name:** Jonsson Comprehensive Cancer Center #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-03516 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-01-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Boston Scientific Corporation #### Lead Sponsor **Class:** OTHER **Name:** Jonsson Comprehensive Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This phase I/II trial tests the safety, side effects and effectiveness of radioembolization with yttrium-90 (Y-90) in patients with early stage renal cell carcinoma. Y-90 is a radioactive chemical that is incorporated into millions of very tiny glass spheres. These spheres are injected into the artery that feeds the cancer. This process is called radioembolization. Y-90 radioembolization may be a safe and effective treatment for patients with early stage renal cell carcinoma. **Detailed Description:** PRIMARY OBJECTIVE: I. To assess safety and toxicity of Yttrium-90 radioembolization for renal cell carcinoma (RCC). SECONDARY OBJECTIVES: I. To assess tumor response and duration of response, based on Choi, Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST criteria. II. To assess time to disease progression. III. To assess progression free survival and overall survival. IV. To assess stability of renal function via glomerular filtration rate (GFR) and cystatin-C. V. To describe the difference in quality of life before and after treatment using Eastern Cooperative Oncology Group (ECOG) performance status and RCC-specific Quality of Life (QoL) questionnaire. OUTLINE: Patients undergo radioembolization with yttrium Y 90 glass microspheres (TheraSphere) given intra-arterially. Patients undergo angiogram during screening, single proton emission computed tomography (SPECT) scan on study and computed tomography (CT) scan and blood sample collection throughout the study. After completion of study treatment, patients are followed up at 1 day, 1 week, and then monthly for 24 months. ### Conditions Module **Conditions:** - Stage I Renal Cell Cancer - Stage II Renal Cell Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients undergo radioembolization with TheraSphere given intra-arterially. Patients undergo angiogram during screening, SPECT scan on study and CT scan and blood sample collection throughout the study. **Intervention Names:** - Procedure: Angiogram - Procedure: Biospecimen Collection - Procedure: Computed Tomography - Radiation: Radioembolization - Procedure: Single Photon Emission Computed Tomography - Other: Survey Administration - Radiation: Yttrium Y 90 Glass Microspheres **Label:** Treatment (radioembolization, TheraSphere) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment (radioembolization, TheraSphere) **Description:** Undergo angiogram **Name:** Angiogram **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Treatment (radioembolization, TheraSphere) **Description:** Undergo blood sample collection **Name:** Biospecimen Collection **Other Names:** - Biological Sample Collection - Biospecimen Collected - Specimen Collection **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Treatment (radioembolization, TheraSphere) **Description:** Undergo CT scan **Name:** Computed Tomography **Other Names:** - CAT - CAT Scan - Computed Axial Tomography - Computerized Axial Tomography - Computerized axial tomography (procedure) - Computerized Tomography - Computerized Tomography (CT) scan - CT - CT Scan - tomography **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Treatment (radioembolization, TheraSphere) **Description:** Undergo radioembolization **Name:** Radioembolization **Other Names:** - intra-arterial brachytherapy **Type:** RADIATION #### Intervention 5 **Arm Group Labels:** - Treatment (radioembolization, TheraSphere) **Description:** Undergo SPECT **Name:** Single Photon Emission Computed Tomography **Other Names:** - Medical Imaging, Single Photon Emission Computed Tomography - Single Photon Emission Tomography - Single-Photon Emission Computed - single-photon emission computed tomography - SPECT - SPECT imaging - SPECT SCAN - SPET - ST - tomography, emission computed, single photon - Tomography, Emission-Computed, Single-Photon **Type:** PROCEDURE #### Intervention 6 **Arm Group Labels:** - Treatment (radioembolization, TheraSphere) **Description:** Ancillary study **Name:** Survey Administration **Type:** OTHER #### Intervention 7 **Arm Group Labels:** - Treatment (radioembolization, TheraSphere) **Description:** Given intra-arterially **Name:** Yttrium Y 90 Glass Microspheres **Other Names:** - TheraSphere - Y-90 Therasphere **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Measure:** Number of treatment related adverse events **Time Frame:** Up to 2 years **Measure:** Number of serious adverse events **Time Frame:** Up to 2 years #### Secondary Outcomes **Description:** According to Choi, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and modified RECIST. Will be summarized as count and percentage. The corresponding 95% confidence interval (CI) for the ORR will be computed using the methodology of Clopper-Pearson. **Measure:** Overall response rate (ORR) **Time Frame:** Up to 2 years **Description:** According to Choi, RECIST 1.1, and modified RECIST. Will be analyzed by Kaplan Meier methodology. **Measure:** Duration of response **Time Frame:** From the first response and first observation of progressive disease, up to 2 years **Description:** According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented. **Measure:** Renal time to progression **Time Frame:** Up to 2 years **Description:** According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented. **Measure:** Progression free-survival **Time Frame:** Up to 2 years **Description:** Kaplan Meier curves will be presented. **Measure:** Overall survival **Time Frame:** Up to 2 years **Description:** Measured by glomerular filtration rate (GFR), creatinine, and cystatin-C. **Measure:** Change in renal function **Time Frame:** Up to 2 years **Description:** Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson. **Measure:** Proportion of patients receiving subsequent treatment for RCC after study treatment **Time Frame:** Up to 2 years **Description:** Will be summarized using descriptive summaries. **Measure:** Type of subsequent RCC treatment received after study treatment **Time Frame:** Up to 2 years **Description:** Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson. **Measure:** Proportion of patients to undergo curative therapy **Time Frame:** Up to 2 years **Description:** Will be summarized using descriptive summaries. **Measure:** Time to subsequent RCC treatment (local or systemic therapy) **Time Frame:** Up to 2 years **Description:** Correlation between tumoral absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging) **Measure:** Correlation between tumoral absorbed dose, with efficacy and safety **Time Frame:** Up to 2 years **Description:** Correlation between normal tissue absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging) **Measure:** Correlation between normal tissue absorbed dose, with efficacy and safety **Time Frame:** Up to 2 years **Description:** The scale is Eastern Cooperative Oncology Group (ECOG). Scale is 1 to 5, with 5 being the worst outcome. **Measure:** Change in Eastern Cooperative Oncology Group score **Time Frame:** Up to 2 years **Description:** Change in overall quality of life based on patient-reported outcomes **Measure:** Change in quality of life as measured by the SF-36 (QualityMetrics) Quality of Life survey **Time Frame:** Up to 2 years **Measure:** Percentage of subjects with absorbed Y90 dose within range (+/- 20%) of planned dose **Time Frame:** Up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants must be aged ≥ 18 years at the time of screening * Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations * Life expectancy ≥ 12 months * RCC, diagnosed by radiographic imaging and histology * Clinical stage of RCC: T1 or T2a, Cancer stage (N0M0) * 1-2 solid (\> 80% solid) target lesions * Patient not an ideal candidate for partial nephrectomy or thermal ablation at the time of study entry, based on the decision of the institution's multidisciplinary tumor board. Contraindications for partial nephrectomy include inability to potentially partially resect the kidney, high risk of adverse events due to medical comorbidities, or potential high risk of adverse events due to general anesthesia. Contraindications to thermal ablation include potential inability to technically place ablation probes into the tumor, central tumors which risk thermal injury to the renal collecting system * Patient not considered a candidate for long-term active surveillance due to oncologic risk due to tumor growth and/or tumor size * Patient not considered ideal candidates for radical nephrectomy due to surgical comorbidity and/or development of adverse health outcomes * Measurable tumor by RECIST 1.1 criteria * Absence of bilateral renal tumors * Negative serum pregnancy test in females of child-bearing potential; patients who are breast-feeding cannot participate in this trial * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count ≥ 1.5 x 10\^9/L * Absolute lymphocyte count ≥ 1.0 x 10\^9/L * Platelet count ≥ 75 x 10\^9/L * Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m\^2 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment * Screening mapping angiogram demonstrates successful localization of tumor(s), where catheter placement location(s) would allow Y90 to distribute in the intended treatment area, without venous shunting Exclusion Criteria: * Any contraindication to angiography or selective renal artery catheterization * Screening angiography with cone beam CT (CBCT) shows any arterial flow to the gastrointestinal tract uncorrectable by angiographic techniques * Screening angiography with CBCT shows poor tumor targeting that would lead to a dose that does not meet the renal dosing criteria. This typically occurs when a feeding artery to the tumor cannot be identified * Screening angiography demonstrates excessive non-tumoral renal parenchyma will be in the treatment field, that the new baseline glomerular filtration rate will be \< 45 mL/min/1.73 m\^2 * Screening angiography demonstrates renal venous shunting of iodinated contrast that is immediately visible upon arterial injection * Extra-renal metastases, including patients with abdominal lymph nodes \>1.5 cm in shorter axis, or with lung nodules (single lesion, \>1 cm, or multiple smaller lesions with a total diameter \>2 cm) * Brain metastases, leptomeningeal carcinomatosis or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry * Evidence of any tumor invasion into the renal vein, renal artery, or renal collecting system * Any prior radiation therapy to the abdomen, including localized radiation therapy to the index tumor * Concurrent treatment for RCC or treatment in the last 6 months in another clinical study, unless it is an observational study (non-interventional) or during a non-interventional follow-up stage of an interventional study, or prior randomization to this study * History of active primary/acquired immunodeficiency * Presence of renal ureteral stent in the treatment kidney at any time * History of malignancy, other than RCC, within three years, with the exception of adequately treatment carcinoma in situ of the cervix, early squamous cell carcinoma or basal cell carcinoma of the skin, localized prostate cancer, ductal carcinoma in situ, or low-grade endometrial carcinoma with no myometrial invasion (negligible risk of metastases or death 5-year overall survival \[OS\] rate \> 90%) * Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment * A history of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically * Active infection * Female patients who are pregnant or breastfeeding or female patients of reproductive potential who are not willing to employ effective birth control from screening to 6 months after treatment * Unstable chronic disease or evidence of any disease or condition that would place the patient at undue risk and preclude safe use of Y90 microspheres, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent * History of pulmonary insufficiency, measured by oxygen saturation of less than 90% * Solitary kidney * Patient not able to follow the study protocol requirements **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Arshia Mian **Phone:** 310-906-6028 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Saima Chaabane **Phone:** (310)794-8995 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Arshia A. Mian - **Phone:** 310-906-6028 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Saima Chaabane - **Phone:** (310)794-8995 - **Role:** CONTACT ***Contact 3:*** - **Name:** Siddharth A. Padia, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** UCLA / Jonsson Comprehensive Cancer Center **State:** California **Zip:** 90095 #### Overall Officials **Official 1:** **Affiliation:** UCLA / Jonsson Comprehensive Cancer Center **Name:** Siddharth A Padia **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000007680 - Term: Kidney Neoplasms - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5548 - Name: Carcinoma, Renal Cell - Relevance: HIGH - As Found: Renal Cell Cancer - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M10703 - Name: Kidney Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T4906 - Name: Renal Cell Carcinoma - Relevance: HIGH - As Found: Renal Cell Cancer - ID: T1341 - Name: Clear Cell Renal Cell Carcinoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002292 - Term: Carcinoma, Renal Cell ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432023 **Acronym:** I-CLEANED **Brief Title:** Imaging - Clinical Evaluation of Altered Nervous System Drainage **Official Title:** Multi-signal Analysis of the Composition and Movement of Fluid in Various Cerebral Compartments in Healthy Subjects and Subjects With White Matter Pathology #### Organization Study ID Info **ID:** 1022 #### Organization **Class:** OTHER **Full Name:** IRCCS Eugenio Medea ### Status Module #### Completion Date **Date:** 2026-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Ministry of Health, Italy #### Lead Sponsor **Class:** OTHER **Name:** IRCCS Eugenio Medea #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The current study aims to evaluate the aspects of perfusion, fluid diffusivity in the interstitium and the T1 and T2 signal of the PVS and WMH. The current study has the following objectives: a) evaluate the perfusion aspects using the gadolinium-based contrast medium of brain tissues in the short term; b) the direction of flow of fluids at very low speed in the white matter using the DTI sequences configured for this purpose; c) T1-mapping of the lesions of interest. The expected results will help us understand two aspects of neurofluid dynamics: a) how the fluid moves within the central nervous system in the first minutes after the injection of the tracer (in our case the gadolinium-based contrast medium) and b) what is the composition of the fluid within the PVS and WMH and how can investigators characterize them more accurately. **Detailed Description:** Among the various indirect markers of altered drainage of neuroglial waste metabolites, there is the widening of the perivascular spaces (PVS) and the presence of white matter signal alterations. An increase in the number of PVS and their enlargement could represent an indirect marker of obstruction to the drainage of fluids and solutes along the arterial wall at the level of the white matter. This obstruction would also be the basis of tissue hypoxia resulting in the formation of areas of signal hyperintensity in the white matter (White Matter Hyperintensities, WMH) often observed in patients with neurodegenerative diseases and small vessel disease. It is currently unclear what the main drainage route of brain waste metabolites is. Surely there are at least two. The glymphatic theory proposes the entry of the cerebrospinal fluid (CSF) from the subarachnoid space towards the brain parenchyma in a centripetal direction and exit of the metabolic waste along the perivenous spaces. The drainage of metabolic waste could also be explained by the more recent "intramural periarterial drainage" (IPAD) theory which shows elimination along the arterial walls in a centrifugal direction. In magnetic resonance imaging (MRI), the study of solute drainage requires a dynamic evaluation, which is able to evaluate the temporal movement of a tracer. There are several MRI techniques, already described in the literature, which can be used to obtain information relating to perfusion processes and the coupling of neuronal and vascular activity in different brain areas. The circulation of CSF is well known, which is produced largely at the level of the choroid plexuses and is then partly reabsorbed by the arachnoid granulations at the level of the subarachnoid space. Recent studies demonstrate that the CSF re-enters the brain parenchyma in a centripetal manner, crossing the thickness of the gray matter and then the white matter. This movement is regulated by various factors, and in particular by the activity of the smooth muscle cells of the arterial walls, the aquaporin 4 receptors (water channels) and by the chemical-physical properties of the extracellular matrix in the extracellular space. ### Conditions Module **Conditions:** - Neuroinflammation - Autism Spectrum Disorder **Keywords:** - magnetic resonance imaging - autism spectrum disorder - white matter disease - glymphatic system - brain waste clearance ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients with white matter hyperintensities, patients with enlarged perivascular spaces, Focus will be on patients with a clinical diagnosis of muscular dystrophy or autism spectrum disorder or traumatic brain injury. **Intervention Names:** - Diagnostic Test: Magnetic resonance imaging **Label:** Patients #### Arm Group 2 **Description:** Patients who need a diagnostic scan but do not carry a diagnosis of psychomotor or cognitive impairment or without a history of TBI and tumors. No white matter hyperintensities. **Intervention Names:** - Diagnostic Test: Magnetic resonance imaging **Label:** Controls ### Interventions #### Intervention 1 **Arm Group Labels:** - Controls - Patients **Description:** Diagnostic and research scanning using magnetic resonance imaging. **Name:** Magnetic resonance imaging **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Number and distribution of enlarged perivascular spaces **Measure:** Perivascular space count **Time Frame:** once at recruitment **Description:** correlation of parasagittal dura and perivascular count **Measure:** Volume of parasagittal dura **Time Frame:** once at recruitment **Description:** effect of sedation on BOLD signal **Measure:** fMRI signal during sedation **Time Frame:** once at recruitment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients with white matter lesions and/or enlarged perivascular spaces Exclusion Criteria: * have contraindications to the use of contrast medium; * are clinically unstable patients and prolonged sedation is inappropriate * have tumors * contraindications to perform MR. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 2 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients with obvious white matter disease on T2 and FLAIR sequences will be included in this study. In particular patients with recent diagnosis of autism spectrum disorder, traumatic brain injury, Steinert's muscular dystrophy will be included. ### Contacts Locations Module #### Locations **Location 1:** **City:** Bosisio Parini **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nivedita Agarwal, MD - **Phone:** +39 031855 - **Phone Ext:** 398 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Noemi Miscioscia - **Role:** CONTACT **Country:** Italy **Facility:** Scientific Institute IRCCS E. Medea **State:** Lecco **Status:** RECRUITING **Zip:** 23842 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002659 - Term: Child Development Disorders, Pervasive - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000009422 - Term: Nervous System Diseases - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: LOW - As Found: Unknown - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M28591 - Name: Leukoencephalopathies - Relevance: LOW - As Found: Unknown - ID: M2803 - Name: Neuroinflammatory Diseases - Relevance: HIGH - As Found: Neuroinflammation - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: LOW - As Found: Unknown - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000090862 - Term: Neuroinflammatory Diseases - ID: D000067877 - Term: Autism Spectrum Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06432010 **Acronym:** R-FORM' **Brief Title:** Quality of Life and Behavioral Change of Retired Persons **Official Title:** Effect of a Health Check-up Followed by a Collective Coaching on the Quality of Life and Behavioral Change of Retired Persons. A Prospective Study Conducted in Ambulatory. #### Organization Study ID Info **ID:** 2021-A00408-33 #### Organization **Class:** OTHER **Full Name:** Institut Pasteur de Lille ### Status Module #### Completion Date **Date:** 2023-12-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-21 **Type:** ACTUAL #### Start Date **Date:** 2021-06-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2021-10-11 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Institut Pasteur de Lille #### Responsible Party **Investigator Affiliation:** Institut Pasteur de Lille **Investigator Full Name:** Jean-Michel Lecerf **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Researchers have found that the first phase of aging, called "frailty", is insidious, silent and slowly progressive. It begins well before the first signs of aging and possibly before retirement age with physiological reserves that are gradually depleted. Frailty is multifactorial. It is situated between the "robust-vigorous" and "poly-pathological-dependent" stages of aging. This state remains dynamic and above all reversible through screening and awareness of the individual's health determinants as well as motivation to change. The Longevity Pathway was designed to meet several concrete objectives ranging from improving prevention to advancing research on the topic of longevity and aging well. This study aims to evaluate the effect of this personalized support on the quality of life of the consultants, but also on many health parameters, 12 months after the end of the proposed coaching. **Detailed Description:** The study will be carried out on healthy volunteers, retired. The main objective of the study is to evaluate the effect of a health check-up followed by a collective "coaching" type of support on the quality of life of retired people 12 months after the end of the coaching sessions. ### Conditions Module **Conditions:** - Healthy Volunteers **Keywords:** - Nutrition and Physical Activity coaching - Cognition coaching - Longevity - Prevention - Quality of life ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Exploratory prospective, monocentric, ambulatory study ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Initial health check-up → 7 weeks nutrition and physical activity coaching → 2 telephone follow-ups at 3 and 6 months after → Final health check-up (12 months after) **Intervention Names:** - Other: Group nutrition and physical activity coaching **Label:** Group nutrition and physical activity coaching **Type:** OTHER #### Arm Group 2 **Description:** Initial health check-up → 7 weeks cognition coaching → 2 telephone follow-ups at 3 and 6 months after → Final health check-up (12 months after) **Intervention Names:** - Other: Group cognition coaching **Label:** Group cognition coaching **Type:** OTHER #### Arm Group 3 **Description:** The study is controlled by the presence of a control group (non-coaching group). 25 people will be included in the control group. They will only benefit from the initial and final health check-up. **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Group nutrition and physical activity coaching **Description:** Group nutrition and physical activity coaching consists of an initial health check-up, followed by nutrition and physical activity coaching sessions over 7 weeks, 2 telephone follow-ups at 3 and 6 months and finally a final health check-up, 12 months after the end of the group nutrition and physical activity coaching sessions. **Name:** Group nutrition and physical activity coaching **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Group cognition coaching **Description:** Group cognition coaching consists of an initial health check-up, followed by cognition coaching sessions over 7 weeks, 2 telephone follow-ups at 3 and 6 months and finally a final health check-up, 12 months after the end of the cognition coaching sessions. **Name:** Group cognition coaching **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Health quality will be evaluated thanks to a health quality questionnary validated by the World Health Organisation (WHO). **Measure:** Change from baseline on quality of life of retired people 12 months after the end of the coaching sessions. **Time Frame:** 1 year #### Secondary Outcomes **Description:** Food behaviors will be measure with Balance and dietary diversity questionnaire proposed by the Institut Pasteur de Lille **Measure:** Change from baseline on food behaviors at 1 year after the coaching **Time Frame:** 1 year **Description:** Food frequency will be measure with 24-hour reminder of ingestas - Visual analogue scales on changes in eating behavior. **Measure:** Change from baseline on food frequency at 1 year after the coaching **Time Frame:** 1 year **Description:** Food behaviors will be measure with Visual analogue scales on changes in eating behavior from 10 (yes really a lot) to 0 (not at all) **Measure:** Change from baseline on food behavior at 1 year after the coaching **Time Frame:** 1 year **Description:** Visual Analog Scales for Behavioral Change Related to Physical Activity raging from 10 (yes really a lot) to 0 (not at all) **Measure:** Change from baseline on physical activity behaviors at 1 year after the coaching **Time Frame:** 1 year **Description:** Marshall Questionnaire for Physical Activity frequency and two questions to evaluate the sedentarity livestyle level. **Measure:** Change from baseline on physical activity frequency at 1 year after the coaching **Time Frame:** 1 year **Description:** The using test is : • 6 minutes walk test (endurance) Measured in meters **Measure:** Change from baseline on endurance at 1 year after the coaching **Time Frame:** 1 year **Description:** The using test is : • Stand up chair test to calculate the number of raise on 30 seconds **Measure:** Change from baseline on physical performances (lower limbs) at 1 year after the coaching **Time Frame:** 1 year **Description:** The using test is : •Arm curl test to calculate the number of arm bend **Measure:** Change from baseline on physical performances (upper limbs) at 1 year after the coaching **Time Frame:** 1 year **Description:** The using test is : •Flexible trunk and posterior chain of lower limbs Measured by index ranging from 5 (the palms of the hands touch the ground) to 1 (the fingertips reach the lower shins) **Measure:** Change from baseline on flexibility at 1 year after the coaching **Time Frame:** 1 year **Description:** The using test is : Unipodal balance (static balance) Measured in seconds **Measure:** Change from baseline on static balance at 1 year after the coaching **Time Frame:** 1 year **Description:** The using test is : Get up and go test Measured by index ranging from 5 (the worst) to 1 (the best) **Measure:** Change from baseline on mobility at 1 year after the coaching **Time Frame:** 1 year **Description:** The using test is : 4 meters walking speed Measured in seconds **Measure:** Change from baseline on speed at 1 year after the coaching **Time Frame:** 1 year **Description:** The using test is : 2 minutes on the spot knee climb This test explores the muscular strength of the lower limbs, dynamic balance and walking Measured in number of knee climb in 2 minutes **Measure:** Change from baseline on dynamic balance at 1 year after the coaching **Time Frame:** 1 year **Description:** Cognitive performances will be measure with : - Montreal cognitive assessment test (MOCA test) to evaluate mild cognitive dysfunction **Measure:** Change from baseline on cognitive performances at 1 year after the coaching **Time Frame:** 1 year **Description:** It will be measure with : - Working Memory Questionnaire **Measure:** Change from baseline on memory at 1 year after the coaching **Time Frame:** 1 year **Description:** It will be measure with : - Insomnia Severity Index (ISI) to assess sleep quality **Measure:** Change from baseline on sleep quality at 1 year after the coaching **Time Frame:** 1 year **Description:** It will be measure with : - Cohen's Questionnaire **Measure:** Change from baseline on stress management at 1 year after the coaching **Time Frame:** 1 year **Description:** It will be measure with : - Hospital Anxiety And Depression Queqtionnaire (HAD questionnaire to assess anxiety and depression) **Measure:** Change from baseline on anxiety at 1 year after the coaching **Time Frame:** 1 year **Description:** Blood samples will be collected to analyse fasting blood glucose **Measure:** Glucose metabolism **Time Frame:** 1 year **Description:** Blood samples will be collected to analyse: total cholesterol, HDL, LDL, TG **Measure:** Lipids metabolism **Time Frame:** 1 year **Description:** Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2 **Measure:** Anthropometric parameters (Body Masse Index) **Time Frame:** 1 year **Description:** - Waist circumference in centimeters **Measure:** Anthropometric parameters (waist circumference) **Time Frame:** 1 year **Description:** Measurement of body fat by DEXA (Dual X Ray Absorptiometry) for half of the total population : * Body fat in grams * Lean mass in grams * Total mass in grams * Visceral fat mass in grams * subcutaneous fat mass in grams * Bone mineral content in grams **Measure:** Body composition **Time Frame:** 1 year **Description:** Measurement of lean mass by DEXA (Dual X Ray Absorptiometry) for half of the total population : * Body fat in percentage * Lean mass in percentage * Visceral fat mass in percentage * subcutaneous fat mass in percentage **Measure:** Body composition **Time Frame:** 1 year **Description:** Measurement by DEXA (Dual X Ray Absorptiometry) for half of the total population : - Bone mineral density in grams/cm² **Measure:** Body composition (bone mineral density) **Time Frame:** 1 year **Description:** Systolic and diastolic blood pressure to calculate blood pressure **Measure:** Systolic and diastolic blood pressure **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Man or Woman; * Retired; * Having the desire to change his/her lifestyle; * Agreeing to follow the constraints generated by the study (presence during the coaching sessions and the final assessment). * Having signed the informed consent form; * Social insured; Exclusion Criteria: * Presenting a pathology requiring a complementary assessment and/or the implementation of a treatment that could prevent the realization of the coaching or that could modify its effect; * Subject participating in another clinical study or in period of exclusion from another study; * Subject deprived of liberty; * Subject under judicial protection measure; * Whose main investigator or a qualified co-investigator judges that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study;. **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lille **Country:** France **Facility:** NutrInvest - Institut Pasteur de Lille **State:** Nord **Zip:** 59019 #### Overall Officials **Official 1:** **Affiliation:** Institut Pasteur de Lille - NutrInvest **Name:** Jean-Michel LECERF, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431997 **Brief Title:** A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM **Official Title:** Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study #### Organization Study ID Info **ID:** FD153502 #### Organization **Class:** OTHER **Full Name:** Fudan University ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shenzhen Maternity & Child Healthcare Hospital #### Lead Sponsor **Class:** OTHER **Name:** Fudan University #### Responsible Party **Investigator Affiliation:** Obstetrics & Gynecology Hospital of Fudan University **Investigator Full Name:** Yu Xiong **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a randomized controlled trial, aiming to investigate whether a time-restricted eating (TRE) can reduce the incidence of gestational diabetes mellitus (GDM) in high-risk pregnant women. Investigators intend to conduct a 3-month randomized controlled study to compare the effects of 10-hour TRE and habitual eating time on GDM under the same energy intake. **Detailed Description:** Investigators present a multicenter, open-label and parallel-group randomized study. Total 240 women in early pregnancy were randomly assigned to TRE group and SOC (standard of care) group according to the ratio of 1: 1. Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. All participants should follow moderate-intensity physical activity for about 30 minutes every day, and receive diet and exercise counseling during the study period. GDM was diagnosed by 75g oral glucose tolerance test (OGTT) test at 24-28 gestational weeks. ### Conditions Module **Conditions:** - Gestational Diabetes Mellitus - Dietary Habits - Lifestyle Intervention - Randomized Controlled Study **Keywords:** - Gestational Diabetes Mellitus - Metabolic Diseases ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). **Intervention Names:** - Behavioral: Time-limited eating **Label:** TRE(Time-restricted eating group) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. **Label:** SOC (standard of care group) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - TRE(Time-restricted eating group) **Description:** All participants will be instructed to follow a diet of 1800-2200 kcal/d (45-50% of energy from carbohydrate, 15-20% from protein, 25-30% from fat) based primarily on Dietary Guidelines for Chinese Residents (2022), Dietary guidelines for pregnant women and Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022). Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. **Name:** Time-limited eating **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Adherence to the intervention measure by Chinese Dietary Guidelines Compliance Index for Pregnant Women (CDGCI-PW) and by counting the number of days in which participants consumed calories outside the time-window or exceeding the upper limit of the required energy intake. Chinese Dietary Guidelines Compliance Index for Pregnant Women (CDGCI-PW): Scores range from 0-100, with higher score indicating better adherence. **Measure:** Adherence to the intervention **Time Frame:** From 14-26 gestational weeks #### Primary Outcomes **Description:** Diagnosed by the 75g oral glucose tolerance test (OGTT). **Measure:** The incidence of GDM **Time Frame:** 24-28 gestational weeks #### Secondary Outcomes **Description:** Number of newborns with birth weight ≥4000g. **Measure:** Number of newborns with macrosomia **Time Frame:** At delivery **Description:** Number of newborns with birth weight \<2500g. **Measure:** Number of newborns with low birth weight **Time Frame:** At delivery **Description:** Number of newborns with weight lies above the 90th percentile for the gestational age. **Measure:** Number of newborns large for gestational age (LGA) **Time Frame:** At delivery **Description:** Number of newborns with weight lies below the 10th percentile for the gestational age. **Measure:** Number of newborns small for gestational age (SGA) **Time Frame:** At delivery **Description:** The incidence of the condition in which normal traction on the fetal head does not lead to the delivery of the shoulders. **Measure:** Incidence of shoulder dystocia **Time Frame:** At delivery **Description:** Number of newborns with an impairment of the neonate's body function or structure due to an adverse event that occurred at birth. **Measure:** Number of newborns with birth injury **Time Frame:** At delivery **Description:** Number of neonatus with neonatal intensive care unit (NICU) admission. **Measure:** Number of neonatus with neonatal intensive care unit (NICU) admission **Time Frame:** Within the first 28 days after delivery **Description:** Number of neonatus with clinical symptoms including tachypnea, nasal flaring, grunting, retractions (subcostal, intercostal, supracostal, jugular), cyanosis, apnea, bradypnea, irregular breathing, inspiratory stridor, wheeze and hypoxia, etc. **Measure:** Number of neonatus with neonatal respiratory distress **Time Frame:** Within the first 28 days after delivery **Description:** Number of neonatus with venous glucose levels \<2.6mmol/L. **Measure:** Number of neonatus with hypoglycemia **Time Frame:** Within the first 48 hours after delivery **Description:** Jaundice that arises from factors that alter the usual process involved in bilirubin metabolism in the liver that requires treatment. **Measure:** Number of neonatus with pathologic jaundice **Time Frame:** Within the first 28 days after delivery **Description:** Intraventricular hemorrhage (IVH) of II grade or above diagnosed by ultrasound. **Measure:** Number of neonatus with intraventricular hemorrhage (IVH) of II grade or above **Time Frame:** Within the first 28 days after delivery **Description:** Necrotizing enterocolitis (NEC) diagnosed by radiography or surgery. **Measure:** Number of neonatus with necrotizing enterocolitis (NEC) **Time Frame:** Within the first 28 days after delivery **Description:** Number of neonatus managed with assisted ventilation \>24 hours via endotracheal tube. **Measure:** Number of neonatus managed with assisted ventilation >24 hours via endotracheal tube. **Time Frame:** Within 72 hours of birth **Description:** Number of neonatus with septicemia ascertained by blood culture. **Measure:** Number of neonatus with sepsis. **Time Frame:** Within the first 28 days after delivery **Description:** The incidence of deaths among live births during the first 28 completed days of life. **Measure:** The incidence of neonatal death. **Time Frame:** Within the first 28 days after delivery **Description:** Maternal fasting plasma insulin level. **Measure:** The level of maternal fasting plasma insulin **Time Frame:** at 24-28 gestational weeks **Description:** Maternal venous glycosylated hemoglobin A1c (HbA1c) level. **Measure:** The level of maternal HbA1c **Time Frame:** at 24-28 gestational weeks **Description:** Insulin resistance calculated by homeostatic model assessment (HOMA-IR). HOMA-IR=fasting plasma glucose (FPG)× fasting plasma insulin (FINS)/22.5. The higher HOMA-IR value indicates higher severity of insulin resistance. **Measure:** Insulin resistance calculated by homeostatic model assessment (HOMA-IR) **Time Frame:** at 24-28 gestational weeks **Description:** Level of maternal venous low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and total cholesterol. **Measure:** Maternal lipid profile **Time Frame:** at 24-28 gestational weeks **Description:** Maternal change in depression, quality of sleep and quality of life measured by the Patient Health Questionnaire-9 (PHQ-9), Pittsburgh sleep quality index (PSQI) and 12-item Short-Form Health Survey Questionnaire (SF-12) according to pre-pregnancy status and 24-28 gestational weeks. The Patient Health Questionnaire-9 (PHQ-9): Scores range from 0 to 27, with higher scores indicating severer depression. The standard cut-off score for screening to identify possible major depression is 10 or above. Pittsburgh sleep quality index (PSQI): Scores range from 0 to 21, with higher scores indicating worse sleep quality. 12-item Short-Form Health Survey Questionnaire (SF-12): physical component score (PCS) range from 0 to 100, higher scores are better. **Measure:** Maternal change in depression, quality of sleep and quality of life **Time Frame:** From pre-pregnancy to 24-28 gestational weeks **Description:** Measured according to pre-pregnancy weight and weight at 24-28 gestational weeks. **Measure:** Gestational weight gain **Time Frame:** From pre-pregnancy to 24-28 gestational weeks **Description:** Measured according to pre-pregnancy waist circumference and waist circumference at 24-28 gestational weeks. **Measure:** Change in waist circumference **Time Frame:** From pre-pregnancy to 24-28 gestational weeks **Description:** Incidence of hypertensive disorders of pregnancy, hydramnios, placental abruption, preterm/prelabor rupture of membranes (P/PROM), preterm birth, chorioamnionitis, postpartum hemorrhage and still birth. **Measure:** Incidence of maternal morbidities **Time Frame:** From 24-28 gestational weeks to delivery ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: 1. Aged 18-50 years; 2. The risk for GDM includes overweight or obesity (BMI ≥ 24 kg/m2 before pregnancy), first-degree relative with diabetes, history of cardiovascular disease, hypertension (≥130/80 mmHg or on therapy for hypertension), HDL cholesterol level \< 1 mmol/L and/or a triglyceride level \> 2.8 mmol/L, history of GDM, history of macrosomia delivery, individuals with polycystic ovary syndrome, repeated positive fasting urine glucose in the first trimester, or age\>45 years according to Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022); 3. Less than 14 weeks of gestation; 4. Able to read and complete questionnaires in Chinese; 5. singleton pregnancy. Exclusion criteria: 1. Pregestational diabetes (including diabetes diagnosed before conception; fasting blood glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester; typical symptoms of hyperglycemia or hyperglycemic crisis with optional blood glucose ≥ 11.1 mmol/L); 2. Impaired glucose tolerance (including fasting blood glucose ≥ 5.6 mmol/L or two fasting blood glucose ≥ 5.1 mmol/L in the first trimester); 3. Current or recent use of drugs that affect glucose metabolism such as metformin, glucocorticoids and Orlistat; 4. Severe comorbidities (including cardiac diseases, kidney diseases, hepatopathy, autoimmune diseases, uncontrolled thyroid disease, previous or current malignant tumors, etc.); 5. Fetal malformations or chromosomal abnormalities; 6. Cervical insufficiency (including ultrasonic cervical length \< 25 mm before 24 weeks of gestation, history of spontaneous preterm birth at 14-36 weeks of previous pregnancy, or cervical dilation in the past or current pregnancy); 7. Exercise contraindications (including continuous vaginal bleeding, threatened premature labor, placenta previa, premature rupture of membranes, severe anemia, etc.); 8. Drug abuse, which refers to the repetitive, heavy use of drugs with dependent characteristics such as narcotic, psychotropic substances, tobacco and alcohol; 9. Hyperemesis gravidarum, which refers to the severe and persistent nausea and vomiting, unable to eat or eat little that leads to dehydration, ketosis and even acidosis; 10. On a special or prescribed diet for other reasons; 11. Eating window\<10 h. Exit criteria： 1. Failure to comply with or assume the corresponding responsibilities and obligations of the informed agreement; 2. Pregnant women who terminate their pregnancy before completing GDM diagnosis and screening at 24-28 weeks of pregnancy will automatically withdraw from the group, such as severe fetal malformation, eclampsia, abortion, etc. 3. Major diseases, such as particularly serious obstetric medical events, malignant tumors, serious cardiovascular and cerebrovascular diseases, brain injuries, paralysis and other major diseases, can not continue to accept this intervention plan and follow-up, and withdraw from the study; 4. Accidental disability or death caused by non-intervention factors occurred during the study period, and he withdrew from the study; 5. Subjects are subjectively unwilling to continue to accept the intervention program, and sign the withdrawal agreement to withdraw from the group on a voluntary basis, and decide whether to continue to follow up the pregnancy process and outcome according to the specific contents of the withdrawal statement. **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ying Zhao, PhD **Phone:** 13061860396 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M19012 - Name: Diabetes, Gestational - Relevance: HIGH - As Found: Gestational Diabetes Mellitus - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016640 - Term: Diabetes, Gestational - ID: D000003920 - Term: Diabetes Mellitus ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431984 **Acronym:** PSK **Brief Title:** Pharmacology Space Kit (PSK) - Dried Blood Spot for Caffeine Pharmacokinetics Under Microgravity Conditions **Official Title:** Kit de Pharmacologie Spatial - Analyse de l'Utilisation Des Dried Blood Spot Pour le Dosage de la caféine Chez Des Volontaires Sains en microgravité au Cours Des Vols Paraboliques #### Organization Study ID Info **ID:** C22-80 #### Organization **Class:** OTHER_GOV **Full Name:** Institut National de la Santé Et de la Recherche Médicale, France #### Secondary ID Infos **Domain:** IDRCB **ID:** 2022-A02794-39 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2024-04-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-03 **Type:** ACTUAL #### Start Date **Date:** 2023-03-27 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Institut National de la Santé Et de la Recherche Médicale, France #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The PSK study is preliminary to the study of drug metabolism in space flight conditions. The investigators propose to use simplified blood sampling methods that can be applied in microgravity. This method is based on the use of capillary blood, obtained using an automatic lancet for diabetics, the blood droplet then being deposited on specific blotting paper, and then studied in the laboratory. In 2022, the investigators validated the transfer of artificial blood in parabolic flight conditions, as well as the validity of cardiovascular drug dosage. The objective of the 2023 study is to validate the collection and transfer of capillary blood, on themselves, by healthy volunteers with little training, for the blood dosage of caffeine after intake of standard doses of alimentary caffeine. The primary objective is a feasibility of 90% of sampling in microgravity, compared with 95% on ground. Secondary objectives are the pharmacokinetic of different forms of caffeine, according to genetic background and other modifiers of CYP1A2. **Detailed Description:** The investigators propose to use simplified blood sampling methods that can be applied in microgravity. This method is based on the use of capillary blood, obtained using an automatic lancet for diabetics, the blood droplet then being deposited on specific blotting paper, and then studied in the laboratory. The objective of the study is to validate the collection and transfer of capillary blood from finger prick test, performed on themselves, by healthy volunteers after a short training, for the blood dosage of caffeine. Dietary caffeine will be used, issued from standardized espresso, tea or dark chocolate. Caffeine is a universally used food substance and is metabolised by a pathway common to many drugs (CYP 1A2). The aim is to show that it is possible to collect blood in this way, and to carry out assays of caffeine. Secondary objectives are to assess the kinetics of caffeine metabolism through the metabolic ratio (AUC paraxanthine/AUC caffeine), and to correlate these kinetics with genetic variations in CYP 1A2 activity. Participants are healthy volunteers already selected to take part in the parabolic flight campaign. A success rate of 95% for ground sampling, and 90% for in-flight sampling is assumed as satisfactory. If 5 volunteer participants during the 3 days of flying carry out 2 in-flight samplings, this results in 30 in-flight samplings. If the other 25 flying volunteers take only one in-flight sample, means 25 in-flight samples (total 55). On the ground, the 30 volunteers will take 90 samples, for a total of 145 minimum samples. An equivalence threshold for a maximum 20% difference between flight and ground conditions is considered. For a difference of 10, 15 and 20%, the power is 34, 79 and 97% respectively. It can therefore conclude that the difference between the two sampling conditions is not clinically significant. ### Conditions Module **Conditions:** - Drug Mechanism - Metabolism Medication Toxicity - Space Motion Sickness ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants are healthy volunteers selected by the investigating team. The size of the study is limited by the number of individuals authorised to board the aircraft. The flying participants in the experiment will be the aircraft crew, i.e. volunteers from the research teams taking part in the parabolic flight. Healthy volunteers over the age of majority will be included in the study. **Intervention Names:** - Diagnostic Test: prick test **Label:** Healthy subjects **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy subjects **Description:** self-sampling of capillary blood using the finger prick test method **Name:** prick test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** A blood transfer is considered as successful IF the 3 following criteria are fulfilled 1. Blood spot covering \> 8 mm2 (3 mm punch circle) 2. Obtaining a drop of blood within the allotted time of 22 sec of microgravity 3. The drop is neither smeared nor smashed on the blotting paper **Measure:** Percentage of valid capillary blood deposit on dry support **Time Frame:** through study completion, an average of 3 days #### Secondary Outcomes **Description:** Identification of self-sampling failure factors * Deposition time in flight \> 22 seconds of weightlessness * Blood stain covering 80% or more of the reference circle: diameter of the stain taken by photography **Measure:** Identification of factors leading to self-sampling failure a. Time too short b. Insufficient drop c. Inadequate transfer **Time Frame:** through study completion, an average of 1 year **Description:** Area under the curve of caffeine and paraxanthine, metabolic ratio (para/caffeine) **Measure:** Caffeine kinetic under different formulations and dosages **Time Frame:** through study completion, an average of 3 days **Description:** Area under the curve of caffeine and paraxanthine, metabolic ratio (para/caffeine) **Measure:** Caffeine kinetic under different CYP1A2 genotypes **Time Frame:** through study completion, an average of 3 days **Description:** Area under the curve of caffeine and paraxanthine, metabolic ratio (para/caffeine) **Measure:** Caffeine kinetic under different gravity conditions **Time Frame:** through study completion, an average of 3 days **Description:** A paper questionnaire will be handed out just after the parabolic flight at the time of the last sampling. It will be made up of closed questions based on 3 dimensions of satisfaction: * The quality of the information given by the investigating team on the capillary blood sampling process in order to improve our paper-based operating procedure. * Their physical and psychological well-being during the finger prick test demonstration phase before the flight, during the flight and at the end of the flight campaign to ensure that the participants felt comfortable and confident in the sampling situation. * Assessment of their performance during the study in flight and on the ground, and whether they would be interested in self-sampling for a future space mission. **Measure:** Acceptability **Time Frame:** through study completion, an average of 1 year **Description:** Area under the curve of caffeine and paraxanthin, metabolic ratio (para/caffeine) at 6 months interval * Visual appearance (degradation, colour change, etc.) * Comparison of relative areas obtained during the study with those obtained in a conventional laboratory situation **Measure:** Stability of dry blood spots **Time Frame:** through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Be affiliated to a social security scheme or benefit from such a scheme. * Have obtained a medical certificate stating that they are fit for parabolic flights. * Be aged between 18 and 70 * Be in good health: no chronic treatment that could interact with the metabolism of caffeine, no progressive disease * Must not have any contraindications to taking caffeine (30 to 100 mg). Volunteers will also be asked not to consume caffeine (coffee, chocolate, energy drinks, tea, cola, etc.) in the 24 hours preceding the experiment. Exclusion Criteria: * Be the subject of a legal protection measure (safeguard of justice, curatorship or guardianship) * suffer from haematophobia (irrational fear of blood) * Have a current infectious disease, particularly viral * Have an active chronic illness * Have a high usual intake of caffeine (\>4 espressos, \>4 cups of tea, \>100g dark chocolate per day) * Total intolerance to all forms of caffeine * Smoke more than 20 cigarettes a day * Have weaned themselves off smoking for less than a month * Have a history of severe Raynaud's phenomenon * Have a history of naupathy * Suffering from naupathy during a flight **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mérignac **Country:** France **Facility:** AIRBUS A 310 - Zero-G **Zip:** 33700 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12002 - Name: Motion Sickness - Relevance: HIGH - As Found: Motion Sickness - ID: M20593 - Name: Space Motion Sickness - Relevance: HIGH - As Found: Space Motion Sickness - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009041 - Term: Motion Sickness - ID: D000018489 - Term: Space Motion Sickness ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5373 - Name: Caffeine - Relevance: LOW - As Found: Unknown - ID: T370 - Name: Caffeine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431971 **Brief Title:** Estimates of the Short-term Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease **Official Title:** Estimates of the Short-term Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease: A Randomized, Placebo-controlled, Double-blinded, Parallel 2-arm, Multi-centre Pilot Trial #### Organization Study ID Info **ID:** LIBRA (TLN/PD/2) #### Organization **Class:** INDUSTRY **Full Name:** InnoMedica Schweiz AG ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** InnoMedica Schweiz AG #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is double-blinded placebo controlled to estimate the short-term efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 18 times intravenously as an add-on therapy to the standard of care Parkinson medication. Talineuren is a liposomal formulation containing GM1 (monosialotetrahexosylganglioside) as the pharmacological active substance. The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial. **Detailed Description:** The ganglioside lipid GM1 (monosialotetrahexosylganglioside) has attracted attention in scientific literature as a promising neuroprotective agent. Research suggests that GM1 ganglioside holds promise not only in the treatment of neurodegenerative disorders like Parkinson disease (PD) and Alzheimer's disease but also in promoting nerve regeneration post-injury. Furthermore, investigations into its potential to improve cognitive function and memory underscore its versatility as a therapeutic agent. Numerous clinical studies have demonstrated its therapeutic potential in treating (PD) patients. Talineuren (TLN) represents a novel approach to harnessing the therapeutic benefits of GM1. TLN is a liposomal formulation, comprising GM1 as its pharmacologically active ingredient, which is expected to cross the blood-brain barrier more efficiently as free GM1 and therefore is able to deliver more GM1 to the brain. This innovative composition is designed to optimize the neuroprotective effects of GM1. Study Description: This study is designed as a double-blinded, placebo-controlled trial to evaluate the short-term efficacy of TLN in PD management. The investigational Medicinal Product (IMP), TLN, is weekly intravenously administered 18 times as an add-on therapy alongside patients' current standard-of-care PD medication. Talineuren, encapsulating GM1 within liposomes, is anticipated to facilitate enhanced delivery and bioavailability of the neuroprotective agent, GM1. Objectives: The primary objective is to obtain statistical estimates of change from baseline and variance for TLN and placebo and to compare these between groups for MDS-UPDRS part III score in the "off" medication state (i.e. Levodopa challenge test (LCT); motor symptoms evaluated by physician). Secondary objectives are to obtain the change from baseline and variance of TLN and placebo and compare these between the groups for : * MDS-UPDRS total score (part I + part II + part III "off" + part IV) * MDS-UPDRS part I (non-motor symptoms in daily life) * MDS-UPDRS part II (motor symptoms in daily life) * MDS-UPDRS part III "on medication" * MDS-UPDRS total part IV (motor complications) * Proportion of patients meeting or exceeding the minimum clinically important difference (MCID) in motor and non-motor symptoms (MDS-UPDRS) and quality of life (PDQ-39) over time * Quality of life (PDQ-39) * Mental condition (MoCA) * Parkinson medication (LEDD) Research objectives (biomarkers): -Assessment of literature-described biomarkers (prognostic, predictive, monitoring and/or response biomarkers) pre- and post-TLN or placebo intervention. Through evaluation and statistical analysis, this study seeks to elucidate the therapeutic potential of TLN in addressing the multifaceted challenges of Parkinson's disease. By providing insights into treatment efficacy, medication usage, symptom management, and quality of life improvements, our findings aim to inform future advancements in PD management and enhance patient care. The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial. ### Conditions Module **Conditions:** - Parkinson Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive standard of care PD treatment + 720 mg of Talineuren i.v. weekly for 18 infusions (18 weeks). **Intervention Names:** - Drug: Talineuren **Label:** Talineuren **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive standard of care PD treatment + placebo (0.9% NaCl) i.v. weekly for 18 infusions (18 weeks). **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Talineuren **Description:** Talineuren infusion weekly **Name:** Talineuren **Other Names:** - TLN - Liposomal GM1 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo infusion weekly **Name:** Placebo **Other Names:** - 0.9% NaCl **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Incidence and severity of treatment-emergent AEs (TEAEs) from the start of the treatment until the safety visit (week 22) using CTCAE criteria (V5.0). **Measure:** Number of IMP-related adverse events **Time Frame:** From the date of the first administration until week 22 **Description:** Collecting of information for a subsequent larger phase II trial. The following information will be assessed: * Acceptance proportion: the proportion of patients willing to participate in this trial * Drop-out proportion \& reason: the proportion of enrolled subjects who pre-maturely discontinue the trial. The reason for the discontinuation shall be recorded, if possible, so to be able to identify any potential issues in the design and procedures of the trial that can be improved for the subsequent trial. * Failure proportion of IMP-administration: Proportion of visits that need to be rescheduled because no vein for IMP-administration is found. **Measure:** Proportion of feasibility parameters **Time Frame:** Up to week 22 **Description:** -To detect and assess the presence of blood-derived biomarkers selected from literature at baseline and end of intervention, and to compare the obtained values in between treatment groups **Measure:** Mean values of Biomarkers **Time Frame:** Baseline, week 19 #### Primary Outcomes **Description:** The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used by the patient and physician to evaluate various symptoms of Parkinson disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS Scale consists of 4 parts: * Part 1 (Nonmotor aspects of experiences of daily living) with 13 items. * Part 2 (Motor aspects of experiences of daily living) with 13 items. * Part 3 (Motor examination) with 18 items. * Part 4 (Motor complications) with 6 items. Each item is rated with 0=normal, 1=slight, 2=mild, 3=moderate, 4=severe. The lower the score, the fewer / less severe the symptoms. **Measure:** Movement Disorder Society Unified Parkinson's Disease Rating Scale score **Time Frame:** Baseline, week 7, 11, 15, 19 and 22 #### Secondary Outcomes **Description:** Parkinson disease Quality of Life Questionnaire (PDQ-39) will be completed by the patient. The proportion of patients reaching or exceeding the minimal clinical important difference (MCID) will be assessed. This questionnaire consists of 39 items in 8 dimensions with 0 = perfect health, 100 = worse health. **Measure:** Parkinson disease Quality of Life Questionnaire score **Time Frame:** Baseline, week 19 **Description:** Patient's mental condition is assessed using the Montreal Cognitive Assessment (MoCA) by the physician together with the patient where the patient can reach a score of 0-30. A final total score of 26 and above is considered normal. **Measure:** Montreal Cognitive Assessment score **Time Frame:** baseline, week 19 **Description:** Levodopa equivalent daily dose (LEDD) in \[mg\] will documented at each study visit. **Measure:** Change in Levodopa equivalent daily dose **Time Frame:** Through study completion, an average of 22 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Informed consent as documented by signature. 2. Male and female subjects, aged 30 to 85 years. 3. Confirmed PD according to British brain bank criteria. 4. Hoehn and Yahr Stage 0 - 2.5 on medication. 5. Stable dopaminergic PD treatment (including DBS) for a month at least. 6. Absence of dementia confirmed by cognitive testing (MoCA ≥24). Exclusion Criteria: 1. Previous treatment with Talineuren (i.e. participants from NEON trial are not allowed) 2. Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational products. 3. Women who are pregnant or breast feeding, or planning to become pregnant during the course of the trial or in the 12 weeks following the trial. 4. Lack of safe contraception, defined as: * Female participants of childbearing potential, not willing to use double method of contraception (hormonal and mechanical) for the entire study duration. Note: Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * Male participants, not using and not willing to use a medically reliable method of contraception for the entire study duration, such as condoms or who are not using any other method considered sufficiently reliable by the investigator in individual cases. 5. Other clinically significant concomitant diseases states (e.g., renal failure, hepatic dysfunction, cardiovascular disease etc.) that is are not under stable control. 6. Known or suspected non-compliance, drug or alcohol abuse. 7. Inability to follow the procedures of the trial, e.g., due to language problems, psychological disorders etc. of the participant. 8. Participation in another trial with an investigational drug within the 30 days preceding and during the present trial. 9. Enrolment of the investigator, his/her family members, employees and other dependent persons. 10. Subject has an atypical parkinsonian syndrome or secondary parkinsonism. 11. Patients with comorbidity that may interfere with the course of the trial. 12. Patients who are not considered to be eligible to participate in clinical trial by the investigator. 13. Patients in adjustment of deep brain stimulation (DBS) parameters 14. Patients with known impaired granulopoiesis **Maximum Age:** 85 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Konolfingen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Michael Schüpbach, Dr. med. - **Phone:** +41 31 790 01 30 - **Role:** CONTACT ***Contact 2:*** - **Name:** Michael Schüpbach, Dr. med - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Switzerland **Facility:** Neurologisches Institut Konolfingen **Zip:** 3510 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431958 **Acronym:** DDBIOS **Brief Title:** Droplet Digital PCR and PCR-free BIOSensors for the Detection of Resistance-associated SNPs in Pneumocystis Jirovecii **Official Title:** Droplet Digital PCR and PCR-free BIOSensors for the Detection of Resistance-associated SNPs in Pneumocystis Jirovecii #### Organization Study ID Info **ID:** 29BRC24.0085 - DDBIOS #### Organization **Class:** OTHER **Full Name:** University Hospital, Brest ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Brest #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The main objective of the proposed research is to identify Pneumocystis jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase (DHPS), dihydrofolate reductase (DHFR), cytochrome b (CYB), inosine-5'-monophosphate dehydrogenase (IMPDH) and therefore to assess the prevalence of potentially resistant strains in patients infected with P. jirovecii. **Detailed Description:** Pneumocystis jirovecii (P. jirovecii) is an opportunistic pathogenic fungus responsible for pulmonary infection or Pneumocystis pneumonia (PCP) in immunocompromised patients. There is currently no system for its in vitro culture. The diagnostic methods used are mainly based on molecular biology techniques which also allow the detection and analysis of single nucleotide polymorphisms (SNPs), particularly at the level of genes coding for the targets of molecules widely used in the prevention and treatment of PCP. These SNPs may represent missense mutations potentially associated with treatment resistance. They may result from exposure of patients to these treatments before the development of P. jirovecii infection. However, data concerning the prevalence of these mutations remains scarce, particularly in France. Methods for detecting these mutations based on PCR followed by DNA sequencing have limitations in terms of sensitivity. The evaluation of new, more sensitive and rapid tools for the detection and characterization of pathogens in this context is necessary. The main objective of the proposed research is to identify P. jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase (DHPS), dihydrofolate reductase (DHFR), cytochrome b (CYB), inosine-5'-monophosphate dehydrogenase (IMPDH) and therefore to assess the prevalence of potentially resistant strains in patients infected with P. jirovecii. The secondary objectives are: * to determine the factors associated (e.g. exposure to treatments) with mutant P. jirovecii strains * to determine the impact of mutations on the effectiveness of anti-Pneumocystis treatment (e.g. favorable vs. unfavorable evolution of the infection) * to evaluate two methods - digital droplet PCR and biosensors without PCR - for the detection and characterization of mutations associated with resistance in Pneumocystis jirovecii ### Conditions Module **Conditions:** - Pneumocystis Pneumonia **Keywords:** - Pneumocystis jirovecii - mutant - anti-microbial resistance - DHPS - DHFR - Cytochrome b - IMPDH ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Measure:** to determine the impact of mutations on the effectiveness of anti-Pneumocystis treatment (e.g. favorable vs. unfavorable evolution of the infection) **Time Frame:** 1 month and 3 month **Measure:** to evaluate two methods - digital droplet PCR and biosensors without PCR - for the detection and characterization of mutations associated with resistance in Pneumocystis jirovecii **Time Frame:** at inclusion #### Primary Outcomes **Description:** Four genes encoding therapeutic targets such as dihydropteroate synthase (DHPS), dihydrofolate reductase (DHFR), cytochrome b (CYB), inosine-5'-monophosphate dehydrogenase (IMPDH) will be amplified and sequenced to detect single nucleotide polymorphisms (Single Nucleotide Polymorphism, SNP), in particular those potentially linked to resistance to anti-Pneumocystis treatments. **Measure:** Presence of specific strains of Pneumocystis jirovecii potentially resistant to treatments in patients infected with this fungus **Time Frame:** at inclusion #### Secondary Outcomes **Measure:** to determine the factors associated (e.g. exposure to treatments) with P. jirovecii mutant strains **Time Frame:** at inclusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients in whom P. jirovecii was detected in a pulmonary sample (bronchoalveolar lavage, sputum, bronchial aspiration, oropharyngeal rinse, nasopharyngeal sample) * No opposition * Patient affiliated to a social security system Exclusion Criteria: * Patients under legal protection (guardianship, curatorship) * Refusal to participate **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients in whom P. jirovecii was detected in a pulmonary sample (bronchoalveolar lavage, sputum, bronchial aspiration, oropharyngeal rinse, nasopharyngeal sample) can be included in the study ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gilles NEVEZ **Phone:** 0298345091 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Solène LE GAL **Phone:** 0298345094 **Role:** CONTACT #### Locations **Location 1:** **City:** Brest **Country:** France **Facility:** Chu Brest **Zip:** 29609 ### IPD Sharing Statement Module **Access Criteria:** Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement **Description:** All collected data that underlie results in a publication **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Data will be available beginning three years and ending fifteen years following the final study report completion ### References Module #### References **Citation:** Hoffmann CV, Nevez G, Moal MC, Quinio D, Le Nan N, Papon N, Bouchara JP, Le Meur Y, Le Gal S. Selection of Pneumocystis jirovecii Inosine 5'-Monophosphate Dehydrogenase Mutants in Solid Organ Transplant Recipients: Implication of Mycophenolic Acid. J Fungi (Basel). 2021 Oct 10;7(10):849. doi: 10.3390/jof7100849. **PMID:** 34682270 **Citation:** Argy N, Le Gal S, Coppee R, Song Z, Vindrios W, Massias L, Kao WC, Hunte C, Yazdanpanah Y, Lucet JC, Houze S, Clain J, Nevez G. Pneumocystis Cytochrome b Mutants Associated With Atovaquone Prophylaxis Failure as the Cause of Pneumocystis Infection Outbreak Among Heart Transplant Recipients. Clin Infect Dis. 2018 Aug 31;67(6):913-919. doi: 10.1093/cid/ciy154. Erratum In: Clin Infect Dis. 2019 Jan 1;68(1):175. **PMID:** 29514207 **Citation:** Bonnet PL, Hoffmann CV, Le Nan N, Bellamy L, Hoarau G, Flori P, Demar M, Argy N, Morio F, Le Gal S, Nevez G. Atovaquone exposure and Pneumocystis jirovecii cytochrome b mutations: French data and review of the literature. Med Mycol. 2023 Sep 4;61(9):myad095. doi: 10.1093/mmy/myad095. **PMID:** 37656874 **Citation:** de la Horra C, Friaza V, Morilla R, Delgado J, Medrano FJ, Miller RF, de Armas Y, Calderon EJ. Update on Dihydropteroate Synthase (DHPS) Mutations in Pneumocystis jirovecii. J Fungi (Basel). 2021 Oct 13;7(10):856. doi: 10.3390/jof7100856. **PMID:** 34682277 **Citation:** Nahimana A, Rabodonirina M, Bille J, Francioli P, Hauser PM. Mutations of Pneumocystis jirovecii dihydrofolate reductase associated with failure of prophylaxis. Antimicrob Agents Chemother. 2004 Nov;48(11):4301-5. doi: 10.1128/AAC.48.11.4301-4305.2004. **PMID:** 15504856 **Citation:** Kojabad AA, Farzanehpour M, Galeh HEG, Dorostkar R, Jafarpour A, Bolandian M, Nodooshan MM. Droplet digital PCR of viral DNA/RNA, current progress, challenges, and future perspectives. J Med Virol. 2021 Jul;93(7):4182-4197. doi: 10.1002/jmv.26846. Epub 2021 Mar 11. Erratum In: J Med Virol. 2024 May;96(5):e29632. **PMID:** 33538349 **Citation:** Pla L, Avino A, Eritja R, Ruiz-Gaitan A, Peman J, Friaza V, Calderon EJ, Aznar E, Martinez-Manez R, Santiago-Felipe S. Triplex Hybridization-Based Nanosystem for the Rapid Screening of Pneumocystis Pneumonia in Clinical Samples. J Fungi (Basel). 2020 Nov 17;6(4):292. doi: 10.3390/jof6040292. **PMID:** 33213011 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008172 - Term: Lung Diseases, Fungal - ID: D000009181 - Term: Mycoses - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000016720 - Term: Pneumocystis Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13910 - Name: Pneumonia, Pneumocystis - Relevance: HIGH - As Found: Pneumocystis - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11169 - Name: Lung Diseases, Fungal - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M19082 - Name: Pneumocystis Infections - Relevance: LOW - As Found: Unknown - ID: T4598 - Name: Pneumocystis Jirovecii Pneumonia - Relevance: HIGH - As Found: Pneumocystis - ID: T4599 - Name: Pneumocystosis - Relevance: HIGH - As Found: Pneumocystis ### Condition Browse Module - Meshes - ID: D000011020 - Term: Pneumonia, Pneumocystis ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06431945 **Acronym:** EDVIP **Brief Title:** Early Detection of HCV in Injection Drug Users **Official Title:** Early Detection of Hepatitis C in Injection Drug Users #### Organization Study ID Info **ID:** UZIS 2023/1 #### Organization **Class:** OTHER_GOV **Full Name:** Institute of Health Information and Statistics of the Czech Republic ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Institute for Clinical and Experimental Medicine **Class:** OTHER **Name:** Brno University Hospital **Class:** OTHER **Name:** České Budějovice Hospital **Class:** OTHER **Name:** University Hospital Hradec Kralove **Class:** OTHER **Name:** University Hospital Olomouc **Class:** UNKNOWN **Name:** Hepatogastroenterology Hradec Kralove **Class:** UNKNOWN **Name:** Regional Hospital Karlovy Vary **Class:** UNKNOWN **Name:** Clinic Podane ruce **Class:** UNKNOWN **Name:** Tomáš Baťa Regional Hospital in Zlín **Class:** UNKNOWN **Name:** Hospital Agel Prostějov **Class:** UNKNOWN **Name:** Hospital Jihlava **Class:** UNKNOWN **Name:** Hospital Havířov **Class:** UNKNOWN **Name:** Hospital Tábor **Class:** UNKNOWN **Name:** Remedis Prague **Class:** UNKNOWN **Name:** Hospital Opava **Class:** OTHER **Name:** Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. **Class:** OTHER **Name:** Military University Hospital, Prague **Class:** UNKNOWN **Name:** Hospital Pardubice #### Lead Sponsor **Class:** OTHER_GOV **Name:** Institute of Health Information and Statistics of the Czech Republic #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The project is a national, prospective, multicenter, non-interventional pilot project of screening HCV in PWID in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Hepatitis C and setting up and testing new methods and implementation into the system of social health care. **Detailed Description:** The project is a national, prospective, multicenter, non-interventional pilot project of screening HCV in PWID in 18 clinical centers in the Czech Republic. The main goal of the project is the elimination of further transmission of hepatitis C virus and to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Hepatitis C and setting up and testing new methods and implementation into the system of social health care. The project will include testing the procedure on a sample of approx. 3,000 PWID which can help to identify weak points in the continuum of care. A methodology for the continuous care of the target group in the early diagnostic and therapeutic stages will be created. Proposal for a system change towards streamlining the screening process. The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0000281. ### Conditions Module **Conditions:** - Hepatitis C Virus Infection **Keywords:** - HCV - PWID - Point of care testing - Hepatitis - Czech Republic - HCV genotype ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 3000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Months ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Hepatitis C antibody (anti-HCV) test - Diagnostic Test: Hepatitis C RNA test and genotype test **Label:** People who inject drugs ### Interventions #### Intervention 1 **Arm Group Labels:** - People who inject drugs **Description:** Testing for hepatitis C antibodies determines whether or not you have been exposed to HCV at some point in your life. This testing will be performed in all 3,000 persons who inject drugs enrolled in the project. **Name:** Hepatitis C antibody (anti-HCV) test **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - People who inject drugs **Description:** RNA is a type of genetic material from HCV that can be detected in the blood. This test will be used as a confirmation of the infection. This testing will be performed in all persons with positive antibody test who will come to clinical center. **Name:** Hepatitis C RNA test and genotype test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of the hepatitis C virus in screened cohort of persons who inject drugs **Time Frame:** Until 31. 12. 2025 #### Secondary Outcomes **Measure:** Up to 3,000 persons who inject drugs (PWID) enrolled in the project **Time Frame:** Until 31. 12. 2025 **Measure:** Optimal methodological settings for early detection of the Hepatitis C virus based on hepatitis C antibody and hepatitis C RNA testing **Time Frame:** Until 31. 12. 2025 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age 18+ * an active injecting drug user or have used injecting drugs at any time in the past Exclusion Criteria: * not agreeing to participate in the project **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Any people who inject drugs with age 18+ tested by cetres participating in the project. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nikola Stourac **Phone:** +42073901254 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lucie Mandelova, PhD **Phone:** +420 770190 828 **Role:** CONTACT #### Locations **Location 1:** **City:** Brno **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Petr Husa, Prof. - **Role:** CONTACT ***Contact 2:*** - **Name:** Petr Husa, Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Brno University Hospital **Status:** RECRUITING **Location 2:** **City:** Brno **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Viktor Mravčík, Assoc. Prof. - **Role:** CONTACT ***Contact 2:*** - **Name:** Marek Bezděk, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Clinic Podane ruce **Status:** RECRUITING **Location 3:** **City:** Havířov **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ivo Mifek, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Ivo Mifek, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Hospital Havířov **Status:** RECRUITING **Location 4:** **City:** Hradec Králové **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Miroslava Volfova, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Miroslava Volfova, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Hepatogastroenterology Hradec Kralove **Status:** RECRUITING **Location 5:** **City:** Hradec Králové **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jaroslav Kapla, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Jaroslav Kapla, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** University Hospital Hradec Kralove **Status:** RECRUITING **Location 6:** **City:** Jihlava **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Josef Škárek, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Romana Kumštarová, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Hospital Jihlava **Status:** RECRUITING **Location 7:** **City:** Karlovy Vary **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kateřina Záleská, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Kateřina Záleská, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Regional Hospital Karlovy Vary **Status:** RECRUITING **Location 8:** **City:** Olomouc **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Květoslava Aiglová, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Květoslava Aiglová, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** University Hospital Olomouc **Status:** RECRUITING **Location 9:** **City:** Opava **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Petr Kümpel, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Petr Kümpel, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Hospital Opava **Status:** RECRUITING **Location 10:** **City:** Pardubice **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Šárka Kropáčková, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Šárka Kropáčková, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Hospital Pardubice **Status:** RECRUITING **Location 11:** **City:** Prague **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Soňa Fraňková, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Soňa Fraňková, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Institute for Clinical and Experimental Medicine **Status:** RECRUITING **Location 12:** **City:** Praha **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Petr Urbánek, Prof. - **Role:** CONTACT ***Contact 2:*** - **Name:** Petr Urbánek, Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Military University Hospital, Prague **Status:** RECRUITING **Location 13:** **City:** Praha **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vratislav Řehák, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Vratislav Řehák, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Remedis Prague **Status:** RECRUITING **Location 14:** **City:** Prostějov **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zdeněk Prokeš, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Zdeněk Prokeš, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Hospital Agel Prostějov **Status:** RECRUITING **Location 15:** **City:** Tábor **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jana Sysová, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Jana Sysová, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Hospital Tábor **Status:** RECRUITING **Location 16:** **City:** Zlín **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ivan Macek, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Ivan Macek, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Tomáš Baťa Regional Hospital in Zlín **Status:** RECRUITING **Location 17:** **City:** Ústí Nad Labem **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Pavel Dlouhý, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Pavel Dlouhý, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. **Status:** RECRUITING **Location 18:** **City:** České Budějovice **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aleš Chrdle, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Aleš Chrdle, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Czechia **Facility:** České Budějovice Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Charles University First Faculty of Medicine **Name:** Viktor Mravcik, assoc. prof. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000004769 - Term: Enterovirus Infections - ID: D000010850 - Term: Picornaviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000018178 - Term: Flaviviridae Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M9592 - Name: Hepatitis A - Relevance: HIGH - As Found: Hepatitis - ID: M9611 - Name: Hepatitis C - Relevance: HIGH - As Found: Hepatitis C - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M1557 - Name: Drug Misuse - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown - ID: M7930 - Name: Enterovirus Infections - Relevance: LOW - As Found: Unknown - ID: M13745 - Name: Picornaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20324 - Name: Flaviviridae Infections - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006506 - Term: Hepatitis A - ID: D000006526 - Term: Hepatitis C - ID: D000006505 - Term: Hepatitis ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: HIGH - As Found: Given - ID: M20971 - Name: Hepatitis C Antibodies - Relevance: HIGH - As Found: Tether - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000906 - Term: Antibodies - ID: D000018937 - Term: Hepatitis C Antibodies ### Misc Info Module - Version Holder: 2024-05-31